Volume 176 Issue 10

A more coordinated, national approach to parasite control would have substantial benefits In January 2000 the World Health Organization launched a program aimed at global elimination by 2020 of the lymphatic filarial parasites Wuchereria bancrofti and Brugia malayi. These parasites together infect in excess of 120 million people, and cause significant morbidity through elephantiasis. A major stimulus to the implementation of this and other programs, such as those aimed at the elimination of leprosy and Chagas' disease, was the successful global elimination of smallpox in 1977, and major advances in programs to control polio, measles, dracunculiasis (guinea worm) and onchocerciasis (river blindness). So, what of Australian parasite control programs? In Australia, endemic malaria and lymphatic filariasis have been eradicated, and leprosy, a once feared and politically significant disease, is in decline through sustained control programs conducted by dedicated public health agencies over long periods using effective drugs. However, the same cannot be said for other common parasitic diseases which are still endemic in Australia, including scabies, giardiasis, cryptosporidiosis, hookworm, strongyloidiasis and trichuriasis. These parasite infections have remained highly prevalent among Indigenous Australians living in the tropical north of the country in areas where infrastructure development has lagged, and improvements in living standards have not matched those seen elsewhere.1-3 Rather than being of trivial importance, such parasite infections cause substantial preventable morbidity. Secondary infection of scabies lesions with group A streptococci contributes to the exceptionally high rates of rheumatic fever and renal disease seen in Indigenous people, while enteric parasites cause a range of adverse health effects, including anaemia from hookworm, septicaemia from strongyloidiasis, and malabsorption and diarrhoea in children from giardiasis and cryptosporidiosis. Further, the merit of control programs for geohelminth infection is supported by studies suggesting benefits in educational outcomes among children treated for these infections.4 Despite the progress made in hookworm control during the course of the Australian Hookworm Control Program in the early part of last century, this infection has remained endemic in many Indigenous communities across our tropical north, and contributes to iron deficiency and anaemia in women and children. The limited success of attempts to control hookworm in one remote northern Australian Indigenous community of about 350 people has been published in the Journal (with rates of hookworm infection documented in 1992 of up to 93% in children 5–14 years of age).2 Recently, our group has published the successful outcome of a 78-month hookworm infection control program in the same community.5,6 This program's success was due to close liaison with the community, the setting of clear goals, and a commitment to improve environmental infrastructure and local health education, as well as regular targeted, population-based chemotherapy over a sustained period. The change of anthelmintic from pyrantel (to which parasite resistance had been demonstrated7) to single-dose albendazole was an additional significant factor in the success of the program. Parasite control programs based on community-wide distribution of albendazole among school-age children have also been implemented in the Northern Territory, and a similar community treatment strategy using permethrin therapy for scabies has recently been shown to reduce the prevalence of scabies in one community from 35% to 3%.3 Such successful programs are useful models for further community programs and national initiatives. Could and should parasitic disease in northern Australia be controlled more effectively? While the determinants of parasitic disease in northern Indigenous communities are complex, there are common themes. Contributing factors include poverty, lack of health knowledge, poor environmental infrastructure and housing, remoteness from health services, family mobility across health regions, and haphazard opportunistic treatment of parasites as they are encountered in clinical practice. To be successful, parasite control programs must be consistent, coordinated and sustained, and accompanied by local health education and improvements in health infrastructure. At present, regional and State parasite control programs lack a consistent approach across primary and secondary sectors and across State borders, and in some regions are ignored or left largely to enthusiasts. A more coordinated, national approach to parasite control would have substantial benefits: It would allow Aboriginal health organisations to fully participate and "own" the program from the national planning level through to the local community, thus facilitating rational debate on this emotive issue; Funding would be made available for nationally agreed strategies and continuing infrastructure improvements in affected communities; The use of standard surveillance techniques, reporting and targets would enable monitoring of progress; The reduction of parasite burden would be achieved through coordinated, programmed use of proven, safe drugs, including albendazole, ivermectin, tinidazole, and permethrin, at a community level; and Programs would be monitored for the development of drug resistance (a problem already present in veterinary practice where related drugs are used8). Two critical factors for the success of such a program are political will, and a will on the part of the communities themselves, together with local healthcare providers, and government and Indigenous health organisations. While the cost of the drugs is not the major barrier to the implementation of such programs, the positive publicity gained by two pharmaceutical companies from their leadership in donating ivermectin and albendazole to the WHO-sponsored filariasis program could have some local lessons. Leadership in Australian parasite elimination programs should come from both the Indigenous and medical communities through an alliance of Indigenous people and public health, infectious diseases and paediatric practitioners.

James S McCarthy · Stuart C Garrow

Australia needs a distinctive “rural health” approach that recognises the valuable role played by the “outback” in our economy and our national psyche The year 2002, the "Year of the Outback", is an opportune time to reflect on why rural health matters and why it continues to be important for Australia. It is the culmination of a decade of initiatives and activity by governments, health organisations and communities seeking to address the "problem of rural health". Rural health emerged in the 1990s as an identifiable field of activity focusing on improving the health status and meeting the specific health needs of people living "out back" of metropolitan areas. The key rural health issues are medical workforce supply, including appropriate training and education; transport and access to appropriate services; funding and costs to patients; and the health status of Aboriginal and Torres Strait Islander peoples in particular, which remains a national shame.1 Under strong pressure from the rural electorate and from advocacy bodies such as the National Rural Health Alliance, there has been a positive government response to rural health issues in recent years. This has included a policy framework that coordinates different levels of government;2 support for advocacy groups and rural professional associations; a significant investment in rural and remote academic infrastructure through the university departments of rural health and rural clinical schools;3 and increased funding for regional and Aboriginal health services. As it is too early to fully evaluate the outcomes of Commonwealth investment in rural health, a sustained effort is required. Rural health issues warrant specific and ongoing attention for a number of reasons. Firstly, outback Australia is different from metropolitan Australia. While the defining characteristic of rural health remains its geography (and related issues of access to healthcare services), rural and remote Australia is also sociologically, culturally, economically and spiritually different from metropolitan areas, as well as internally diverse. It is these characteristics that define the health behaviour of its residents, determine their health status and influence the way health and medical care is provided.4 Nowhere is this more evident than in dealing with the healthcare needs of Aboriginal and Torres Strait Islander peoples in rural and remote regions. Secondly, rural health matters because of health differentials between the city and the outback. Nationally, there is a trend towards a higher mortality rate with increasing remoteness, mostly attributable to the higher proportion of Aboriginal and Torres Strait Islander peoples in remote and very remote regions.5 Given the right of all Australians to optimal health and equitable access to health services, the significantly poorer health status of people in outback Australia remains a fundamental concern. Thirdly, improving rural health is integral to rural and regional development in Australia. Currently, outback Australia fares worst in statistical comparisons of the underlying social determinants of health — namely, housing, employment, income level, education, transport, and social security.6 Good health does not result from access to health services alone. Without a comprehensive regional development policy that focuses on a healthy rural economy, many outback communities face a bleak future — a future characterised by continued poor health status of rural dwellers. Complementary local initiatives based on community empowerment will also be required to address specific problems. Lastly, rural health matters because of the valuable lessons to be learned from the many innovative solutions that have arisen in response to the problems of rural health in Australia. The tyranny of distance, the deficit of resources and the passion of a number of dedicated practitioners to cater for the diverse geographical circumstances of non-metropolitan Australia have resulted in many innovative health sector responses, including the Royal Flying Doctor Service, multipurpose and regional health service models, and telemedicine. Nurse practitioners (a concept currently being trialled in several States) have been working effectively in Australia's remote communities for decades. Australia is a world leader in rural health education, particularly medical education.7,8 Implementation of a true primary health care approach has long characterised the way healthcare is practised and delivered in many small outback communities, particularly by Aboriginal community controlled health services.9 In summary, innovation born of both local need and community action is a hallmark of much rural and remote healthcare practice. Strong rural and regional representation in setting national policy is imperative. Moreover, improved coordination between government departments and between different levels of government on issues affecting rural areas is required. Metropolitan-based clinicians, educators, policymakers and those responsible for implementing health programs should at the very least have an awareness of the geographical, economic and cultural diversity of their constituents and patients. We in the medical profession can collectively continue to press for appropriate health infrastructure, improved access to education and economic opportunities for rural and remote communities. The issue of how the "outback" is defined (whether in terms of "rural" or "remote" areas) is likely to be an ongoing debate, if for no other reason than its significance in terms of resource allocation and monitoring of health outcomes. What should not be in dispute, however, is the need for a distinctive "rural health" approach and national recognition of the valuable role in the Australian economy and psyche played by a healthy "outback" in all its diversity.

John Wakerman MTH, FAFPHM, FACRRM · John S Humphreys BA(Hons), DipEd, PhD

Notification of abuse should trigger initiatives to prevent further abuse and ameliorate adverse consequences There has been concern recently in Australia about the sexual abuse of children by those in authority. Clearly, we expect such people to behave better. However, child sexual abuse is much more likely to involve the ordinary people comprising a child's family and their friends. In 1990 the World Health Organization Global Burden of Disease project1 identified 10 risk factors that, if averted, would reduce the burden of disease by a third (eg, malnutrition, poor sanitation, unsafe sex). For the next revision of the risk estimates, the WHO Collaborating Centre at St Vincent's Hospital, Sydney, was asked to prepare a report on the prevalence and impact of child sexual abuse on health status around the world.2 Here, we comment on the situation in Australia. Child sexual abuse can be subdivided into three levels of severity. Non-contact abuse includes sexual solicitation or exposure by an older person; contact abuse involves genital touching or fondling; and penetrative abuse includes oral, anal or vaginal intercourse by an older person. Prospective studies of the prevalence of child sexual abuse are ethically and legally difficult. Thus, all data are from retrospective reports of men and women asked about their experience of unwanted sexual activity before the age of 18 years. However, establishing the validity of retrospective reports is not easy — only a minority of children who have experienced child sexual abuse report it to their parents, and only a minority of these parents report the abuse to the authorities. Furthermore, unreliable recall represents a threat to the validity of the results. However, follow-up studies show that a false-negative rather than a false-positive bias is the rule.3 Methodological factors like the type of sample used and the number of questions asked to ascertain abuse may also compromise the validity of results. Accordingly, for the WHO study, such method factors were statistically controlled for. Seven studies of child sexual abuse have been performed in Australia.4-12 The adjusted prevalence estimate in males was 5.1% and in females 27.5%, which corresponds with rates in comparable countries. The rates for contact plus penetrative abuse were two-thirds of these (ie, 3.6% in males and 17.9% in females). The onset of abuse occurs at a mean age of 10 years, with most starting before age 12. The abuser is a family member in about 40% of cases, and is known to the child in 75% of cases. The abuser is usually male, mean age 32 years. Child sexual abuse is more frequent in families beset by other adversity, and it is difficult to determine the cause of any increased rate of mental disorders in the presence of an aggregation of risk factors. Two reports of a twin study11,12 that was able to control for the effect of family environment showed increased rates of anxiety, and depressive and substance-use disorders in the abused twin. Rates of suicide attempts were also increased in the abused twin. Child development studies in other countries, in which the family environment was measured independently of sexual abuse or mental disorder, have generated similar results.13,14 People who report contact or penetrative abuse in childhood have double the normal rates of mental disorders and suicide attempts. Attributable risk calculations suggest that 11% of depression in women and 3% of depression in men could be attributed to contact or penetrative abuse in childhood. Quite apart from increased rates of mental disorders, children who have experienced sexual abuse continue for years to show significantly more distress and disturbed behaviour.8 A minority of children are able to surmount this type of adversity and remain unaffected. For those who do not the sequelae can be serious, with great societal costs. What can be done? Teachers and doctors are required to report sexual abuse that comes to their notice. However, this system has the potential to encourage a "don't ask, don't know" attitude. At the same time, it does serve notice to abusers that they are at risk of discovery. In some States, criminal record checks required of anyone who works with children have removed any suggestion that child sexual abuse will be tolerated or excused. Conviction of offenders is not simple, even in the minority of cases in which there is clear medical evidence, as, apart from the child, there are usually no witnesses. Nevertheless, the change in the judicial attitude to child sexual abuse is expected to result in a reduction in incidence. Notification of abuse should trigger other initiatives to prevent further abuse and ameliorate any adverse consequences. Firstly, help for the mother/carer to keep the child safe from further abuse, whether achieved by health visitor support, family counselling, or physical relocation of the family; and secondly, treatment for the child to ensure that disturbed and dysfunctional behaviours and the increased risk of mental disorders do not occur. A recent review of controlled studies of treatment for sexually abused children has provided preliminary evidence that the sequelae can be minimised in the short term.15 It is clear, however, that not all abused children benefit and more research is needed. The management of such children should be driven by science and not simply by compassion.

Gavin Andrews · Bronwyn Gould · Justine Corry

Objective: To compare hospital costs of Aboriginal and non-Aboriginal patients having haemodialysis treatment and forecast the future treatment cost.Methods: The costs of patients with HD in the "Top End" of Australia's Northern Territory were estimated for the financial years 1996/97 and 1997/98 using a hospital costing model. We used an Autoregression Integrated Moving Average model to predict future demand.Results: 165 patients (101 Aboriginal and 64 non-Aboriginal) were treated at a total cost of $12.4 million in this two-year period. These 165 patients represented 0.7% of inpatients, 8.8% of total inpatient costs and 31.6% of total inpatient episodes of care in the Top End region. $9.5 million (77%) was spent on routine haemodialysis treatment and $2.9m (23%) on other hospitalisations. The average cost per routine haemodialysis treatment over the two-year period was $527, or $78 600 per patient treatment year. Hospitalisations for comorbidities occurred in 86% of Aboriginal and 39% of non-Aboriginal patients. Average cost per patient, number of admissions and length of hospital stays were all significantly greater for Aboriginals. We predict an average increase in the number of treatments of 12% each year over the next five years and a five-year cost of $49.8m.Conclusions: A multipronged strategy designed to reduce the prevalence and costs of renal failure is required.

Jiqiong You MSc, MBA, MB BSc · Yuejen Zhao PhD · Carol Beaver MSc · Wendy Hoy FRACP · Kathy Eagar PhD

Objectives: To identify factors limiting the effectiveness of communication between Aboriginal patients with end-stage renal disease and healthcare workers, and to identify strategies for improving communication. Design: Qualitative study, gathering data through (a) videotaped interactions between patients and staff, and (b) in-depth interviews with all participants, in their first language, about their perceptions of the interaction, their interpretation of the video record and their broader experience with intercultural communication. Setting: A satellite dialysis unit in suburban Darwin, Northern Territory. The interactions occurred between March and July 2001. Participants: Aboriginal patients from the Yolngu language group of north-east Arnhem Land and their medical, nursing and allied professional carers. Main outcome measures: Factors influencing the quality of communication. Results: A shared understanding of key concepts was rarely achieved. Miscommunication often went unrecognised. Sources of miscommunication included lack of patient control over the language, timing, content and circumstances of interactions; differing modes of discourse; dominance of biomedical knowledge and marginalisation of Yolngu knowledge; absence of opportunities and resources to construct a body of shared understanding; cultural and linguistic distance; lack of staff training in intercultural communication; and lack of involvement of trained interpreters. Conclusions: Miscommunication is pervasive. Trained interpreters provide only a partial solution. Fundamental change is required for Aboriginal patients to have significant input into the management of their illness. Educational resources are needed to facilitate a shared understanding, not only of renal physiology, disease and treatment, but also of the cultural, social and economic dimensions of the illness experience of Aboriginal people.

Alan Cass FRACP · Anne Lowell PhD · Michael Christie PhD · Paul L Snelling FRACP · Melinda Flack Grad Dip Renal Health · Betty Marrnganyin · Isaac Brown BAppSci

Objectives: To ascertain which factors are most significant in a general practitioner's decision to stay in rural practice and whether these retention factors vary in importance according to the geographical location of the practice and GP characteristics.Design: National questionnaire survey. The method of paired comparisons was used to describe the relative importance of the retention items.Setting: Non-metropolitan Australia, September 2001.Participants: A stratified sample of all rural GPs practising during April–June 2001.Main outcome measures: A rank ordering of factors influencing how long GPs stay in rural practice, and an index of their relative perceived importance.Results: Professional considerations — overwhelmingly, on-call arrangements — are the most important factors determining GP retention in rural and remote areas. Rural doctors consistently ranked on-call arrangements, professional support and variety of rural practice as the top three issues, followed by local availability of services and geographical attractiveness. Proximity to a city or large regional centre was the least important factor. Retention factors varied according to geographical location and GPs' age, sex, family status, length of time in the practice, and hospital duties.Conclusions: A broad, integrated rural retention strategy is required to address on-call arrangements, provide professional support and ensure adequate time off for continuing medical education and recreation.

John S Humphreys BA(Hons), PhD · Judith A Jones BA(Hons), MSPD · Michael P Jones BSc(Hons), PhD · Paul R Mara DipRACOG, FRACGP, FACRRM

Objective: To quantify the barriers to practising as a rural consultant physician.Design: Cross-sectional postal survey.Participants: All 981 practising consultant physicians in Victoria, Australia, who were Fellows of the Royal Australasian College of Physicians in 1999; 52 (100%) of rural physicians and 634 (68.2%) of metropolitan physicians completed the survey.Main outcome measures: Demographic and practice characteristics; barriers to rural practice.Results: There were no rural female consultant physicians, and 35 of the 52 rural consultant physicians (67.3%) were born in a rural area. The most important perceived barriers to rural practice identified by both metropolitan and rural physicians were children's schooling (72.2%), spouse's occupation (65.7%), other issues related to children (66.7%) and difficulties getting back into metropolitan practice (45.7%). Among metropolitan physicians, barriers to rural practice differed by age, sex, place of birth and nationality. Returning to metropolitan practice, children and concern over procedures were more likely to be reported as barriers to rural practice among those aged 40 years or under, 41–50 years and 51 years and over, respectively.Conclusion: The major barriers to rural practice identified by physicians lie outside the health sector, and particularly concern a perceived need for wider opportunities in children's education and spouse employment.

David Simmons FRACP, MD · Les E Bolitho FRACP · Grant J Phelps FRACP · Rob Ziffer FRACP · Gary J Disher

The Department of Rural Health, University of Melbourne, has developed a framework for conducting research in partnership with Indigenous communities. The framework addresses past inappropriate research practices, incorporates cultural understandings, and outlines culturally appropriate protocols. The four parts of the framework are a committee to initiate, direct and oversee all research projects; a Koorie Team to guide research; a set of research guidelines; and a policy for the department. The framework has been used to develop strong relations with Koorie communities and conduct various health projects.

Rick Henderson GradCertAppSc · David S Simmons MD, FRACP · Lisa Bourke MSc, PhD · Janice Muir

The great majority of smokers are chronically dependent on tobacco. This dependence arises from the rituals and sensory associations of smoking that are reinforced, within seconds, by a rapid burst of nicotine from the cigarette. All forms of nicotine replacement therapy (NRT) — gum, patches and inhaler — and bupropion are safe and effective for increasing smoking cessation rates in the short and long terms. Other than those who are minimally dependent, all patients willing to quit should be offered one of these therapies unless contraindications exist. The effectiveness of drug treatments is multiplied when associated with effective counselling or behavioural treatments. While NRT is not recommended during pregnancy or in patients with cardiac disease, if the alternative is smoking NRT is almost certainly safe. Combination NRT (more than one therapy) may be indicated in patients who have failed monotherapy in association with withdrawal symptoms. There are some specific contraindications to the use of bupropion. Its subsidised availability should not influence prescribers to ignore these.

Matthew J Peters MD, FRACP · Lucy C Morgan BMed, FRACP

Thorough definitions and descriptions of the objectives and outcomes in clinical trials lead to results that are more readily interpretable and more easily generalisable. Indeed, the failure to prospectively define both objectives and outcomes in sufficient detail, and to describe how these are to be measured, has been a major criticism of some randomised trials.1 Items 5 and 6 of the CONSORT statement checklist relate to objectives and outcomes in randomised trials.2 ObjectivesThese should be clearly defined, and stated in a manner that will allow the objectives to be investigated by a quantitative assessment of appropriate outcomes. For example, an objective stating ". . . whether allowing free access to heroin will decrease the crime rate . . ." is too vague without a detailed definition of what constitutes a crime and how and when these are to be measured. Loosely stated objectives may appear in studies with a wide range of scientific rigour, and are likely to give rise to scepticism about the trial results, owing to concerns that the definitions may have been created post hoc, with foreknowledge of the study data. Concerns might also arise about studies whose objectives require myriad tests or assessments (eg, psychological, clinical and psychiatric), potentially confusing the reader as to which, if any, evaluated the primary hypothesis. The supporting evidence, outlined in the background and rationale of the study, should be linked logically to the study objectives.3 The outcomes of studies are more convincing when they apply to a single or small number of clearly defined objectives. The objectives should include: a precise statement of the degree of benefit expected from the intervention, as well as the duration of the benefit; clear statements of the time frame of the study (especially in relation to how quickly benefits might commence); and a definition of the patients for whom the benefit is sought.4 Objectives can be classified as either primary or secondary. Primary objectives provide the focus of the study. Collection and measurement of outcomes affecting the primary objective is critical and, if resources are scarce, these take priority over other aspects of the study. An exception to this is that the collection of safety information is always considered of high priority, regardless of whether safety is the focus of the study. It is crucial to minimise missing data related to the primary objective. Secondary objectives allow for investigating subsidiary questions that, while scientifically important, do not have the same priority of clinical interest in the patient group being studied. In most randomised trials, efficacy of the intervention or its equivalence with standard care is the primary objective, whereas safety (eg, toxicity, side effects) is usually a secondary objective. OutcomesAs with the objectives, the outcomes of the trial require precise description and definition. Standard measurement criteria are essential in order for the results to be accepted by the clinical community. For example, in cancer studies, measuring response by tumour area is a widely accepted practice, whereas measuring response by tumour volumes may be questioned by those not routinely using this criterion. The outcomes chosen should be clinically relevant and, where possible, measured in an objective fashion. If objectivity in measurement of outcomes is not possible, some control, on a subjective assessment, is desirable. For example, blinding assessors to treatment allocation provides a powerful tool for reducing measurement bias.5 The frequency of outcome measurement should be clearly stated, as should strategies to be undertaken if the pooled outcome rate is lower than anticipated (eg, adjustment of study sample size). As with objectives, outcomes can be classified as primary or secondary and the same comments relating to primary objectives also apply to the measurement of primary outcomes. If multiple outcomes (eg, liver function test results, or scores on a battery of psychological scales) are measured, precise statements on which aspect of these will be used to investigate the objectives need to be made a priori. The analysis of multiple outcomes requires specialised statistical methods and these should defined in detail in the study protocol and report. Where it is essential to employ multiple outcomes, a priority list detailing which of the outcomes represents the benefit sought should be determined in advance. Thus, for example, if a series of haematological parameters is being measured, then a single parameter (eg, changes in the platelet count) should be defined as the primary outcome. If an outcome is measured repeatedly (eg, muscle strength), the issue of how these repeated measurements will be used to meet the objectives needs to be clearly stated. Thus, an objective considering "the frequency of heroin use in the 28 days before a six-month assessment (ie, during month 5)" will require different outcomes measurement to an objective considering "the average frequency of heroin use over a six-month period". The latter objective would require specification of how often the frequency of heroin use was to be estimated or recorded over the six months. Missing measurements may also become an issue (such as measurement of heroin use in a self-reporting study) and requires careful thought in the design stage. It may be desirable to specify a secondary, "fallback" objective in case data for the primary outcome prove difficult to collect over the study period (a well conducted pilot study would avoid this risk). Surrogate outcomesIn many instances the use of surrogate, or intermediate, outcomes allows for shorter study durations (because surrogate events accumulate faster), with results on the surrogate outcome being translated to an outcome of major clinical interest. A surrogate outcome is one that is intended to capture the treatment effect on an important clinical endpoint, but does not directly measure the main clinical benefit of the intervention. For example, in cancer studies, tumour response, disease-free survival and time to disease progression have been used as surrogates for survival. The conditions under which an outcome is a "good" surrogate are still the subject of research.6 Nevertheless, many surrogate outcomes (eg, elevated tumour marker levels as indicators of tumour activity, such as prostate specific antigen in prostate cancer) provide strong associations with tumour growth as an important question of interest. Statistical methods exist to examine the degree to which a surrogate is associated with a main outcome,7 although these are still being refined. A statement indicating how and how much of any benefit observed in the surrogate will translate to the main clinical outcome should be provided. In clinical studies, where it is not feasible to have adequate statistical power for a clinical endpoint, a valid surrogate may be used as the primary objective, with the main clinical endpoint becoming a secondary objective. 1: CONSORT checklist of items to include when reporting a trial Selection and topic Item no. Description Objectives 5 Specific objectives and hypotheses Outcomes 6 Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (eg, multiple observations, training of assessors) 2: Checklist for objectives and outcomes in clinical trials Objectives Are the intervention and control (eg, usual care) described in detail? Has the the target patient population been specified? Has the degree of benefit from the intervention on a particular outcome, and the time frame, been specified? Has the primary outcome, including how and when it is to be measured, been specified? Have any secondary outcomes been pre-specified in similar detail? Outcomes Are the outcomes clinically relevant, objective (wherever feasible) and unambiguous? Can the outcomes be measured for all patients and, where possible, assessed with researchers blinded to the allocated treatment? Is the study explicit in the frequency and duration of outcome measurement? Has the study been specially planned from a statistical viewpoint when multiple outcomes are measured? If the outcome is a surrogate, will it adequately reflect a main outcome, and is there an indication of how much a benefit observed on the surrogate outcome will translate to a benefit on a main outcome?

Val J Gebski BA, MStat · Ian Marschner BSc, PhD · Anthony C Keech FRACP, MSc(Epi)

QuestionAre levo acetyl methadol (LAAM) and buprenorphine as effective as methadone for substitution treatment of opioid dependence? Trial details Design: Randomised controlled trial, double-blind. Setting: Outpatient clinic in Baltimore, United States. Participants: 220 people categorised as opioid dependent by DSM-IV;1 groups similar on demographics and drug use history. Exclusion criteria were medical and psychiatric illness requiring long-term medication, and pregnancy. Interventions: (i) Levo acetyl methadol (LAAM) at 75–115 mg, (ii) buprenorphine at 16–32 mg, (iii) methadone at 60–100 mg ("high dose"), or (iv) methadone at 20 mg ("low dose"). LAAM and buprenorphine were given three times a week, methadone daily. LAAM and methadone were given orally, buprenorphine sublingually. Participants attended the clinic daily for two weeks of dose induction, then thrice weekly with take-home doses. The scheduled duration of the trial was 17 weeks. Main outcome measures: Retention in treatment; illicit drug use; participants' global ratings of their drug problem. Main results: Days retained in the study (mean ± SE) — LAAM (i), 89 ± 6; buprenorphine (ii), 96 ± 4; "high dose" methadone (iii), 105 ± 4; "low dose" methadone (iv) 70 ± 4. Significantly more days retained for groups (i), (ii) and (iii) compared with group (iv) (P < 0.001), and group (iii) compared with group (i) (P = 0.02). Trial was completed by 53% of group (i), 58% of group (ii), 73% of group (iii), and 20% of group (iv), with 4, 3, 6 and 26 of groups (i), (ii), (iii) and (iv), respectively, transferred to rescue treatment (standard methadone maintenance). Twelve or more consecutive opioid-negative urine specimens were obtained in 36% of group (i), 26% of group (ii), 28% of group (iii) and 8% of group (iv) (P < 0.005). Conclusion: Compared with low-dose methadone, LAAM, buprenorphine and high-dose methadone substantially reduce the use of illicit opioids. CommentaryRationale for the trialSubstitution treatment with methadone has proven effective in reducing heroin use and providing an opportunity for improvement in health and social functioning for dependent drug users.2 However, methadone maintenance does not suit all people. LAAM, a full opioid agonist, and buprenorphine, a partial agonist, are promising alternatives to methadone maintenance. Buprenorphine has a lower risk of overdose than methadone, and both buprenorphine and LAAM can be given less frequently than daily, providing increased flexibility and reduced costs. Previous research supports the feasibility of substitution treatment with LAAM and buprenorphine, and each of these drugs has been compared with methadone in controlled studies.2 The rationale for this trial by Johnson and colleagues was to compare LAAM and buprenorphine with standard ("high dose") methadone maintenance and a control in a single study. Methadone at 20 mg daily was chosen as the control because it has the capacity to suppress opioid withdrawal, but is only minimally effective as a maintenance treatment. For ethical reasons, a rescue treatment was available for all study participants who responded poorly to experimental treatment. Trial methodsParticipants were stratified, then allocated by random number generation, with participants and clinic staff unaware of group assignments and doses. Each day participants received three solutions (two oral, one sublingual), only one of which contained active medication. Otherwise all groups received equivalent treatment. It seems likely that participants in the "low dose" methadone group might have been able to guess their group allocation, but the adequacy of blinding was not discussed by the authors. There were clear definitions for transfer to rescue treatment, drop-out, and calculation of retention in treatment, and adjustments for missing data. All analyses were based on intention to treat. New informationLAAM and buprenorphine are significantly more effective than "low dose" methadone in reducing illicit opioid use, and of similar effectiveness to "high dose" methadone. Illicit opioid use was somewhat lower for the LAAM group — the use of larger group sizes might have provided sufficient statistical power for a significant difference to be detected. Participants in the "high dose" methadone group were retained in treatment for more days, although the difference achieved statistical significance only for "high dose" methadone compared with LAAM. Most of the difference between "high dose" methadone and LAAM occurred in the first two weeks of treatment. Implications for clinical practiceAs most doses are supervised by a pharmacist, the possibility of less than daily dosing is a practical benefit of LAAM and buprenorphine. This trial shows that thrice-weekly dosing with these medications reduces illicit opioid use to a similar extent to that achieved with standard methadone maintenance treatment, and indicates that both buprenorphine and LAAM are more effective than "low dose" methadone. The lower retention rates associated with LAAM make it necessary to have available an alternative therapy for people who do not respond, and to give particular attention to patients during induction. More participants in the LAAM group were withdrawn because of side effects, but the details of these side effects were not reported, and this needs to be explored further. This report did not describe changes in participants' health and social functioning, which are important in considering the overall effectiveness of treatments for opioid dependence. Buprenorphine is available in Australia, but LAAM is available only under clinical trial arrangements.

Linda R Gowing PhD · Robert L Ali MB BS, DipRACOG, GDPH, FAFPHM · Jason M White PhD

Clinical question"Is subcutaneous (SC) or intramuscular (IM) naloxone as effective as intravenous (IV) naloxone in the treatment of life-threatening heroin overdose?" An emergency department clinician was interested in comparing routes of administration of naloxone in light of anecdotal evidence suggesting that various routes may not be equally efficacious in restoring a patient to spontaneous breathing and consciousness. Search questionPatients presenting to an emergency department for the management of a heroin overdose were the focus of the search strategy. The search question was "How long does it take for patients to return to consciousness after administration of naloxone by various routes?". In order to answer this question, a randomised controlled trial comparing the effects of SC or IM versus IV naloxone would be the ideal study design. SearchThe search terms "heroin", "opioid overdose", "naloxone" and "route of administration" were combined to identify relevant English-language articles published between 1966 and June 2000. Databases and websites searched included the Cochrane Library, Best Evidence, PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Smart Search and Bandolier. Studies other than those set in the emergency department (ie, those conducted in hospital wards or post-anaesthetic care units) were excluded, as the clinician had specified that we limit the search to pre-hospital or emergency department settings. The search yielded only one study that compared SC with IV naloxone for treating opioid overdose in this setting. No studies were found comparing the use of IM with IV naloxone. Summary of findingsIn a comparative study using historical controls, Wagner et al1 compared naloxone administered intravenously or subcutaneously to patients in the community with suspected opioid overdose. The two intervention arms were 0.4 mg IV naloxone and 0.8 mg SC naloxone. The study was conducted sequentially in two phases: the IV phase, from 1 June to 30 June 1996, and the SC phase, from 1 July to 1 September 1996. Ambulance attendants in a regional district of British Columbia, Canada, administered naloxone to people meeting the British Columbia Ambulance Services' criteria for suspected overdose (ie, reduced consciousness, history suggestive of opioid use, and respiratory rate of less than 10 breaths per minute). The protocol also included a second dose of SC or IV naloxone if the first dose was not observed to be physiologically effective. The primary outcomes of interest included the time interval from arrival at the patient's side until the respiratory rate rose above 10 breaths per minute, the time interval from arrival at patient's side to naloxone administration, and the duration of bag–valve–mask ventilation. Overall, there was no significant difference between the two modes of naloxone administration with regard to the time interval between arrival at the patient's side and attainment of a respiratory rate greater than 10 breaths per minute (9.3 ± 4.2 minutes [IV] v 9.6 ± 4.6 min [SC]; P = 0.67). There was also no significant difference in duration of respiratory bag–valve–mask ventilation between administration arms (8.1 ± 6.0 minutes [IV] v 9.1 ± 4.8 minutes [SC]; P = 0.20; 95% CI of difference, –2.53 to 0.53). OutcomeWe submitted the report to the emergency physician, stating that the single study in a community setting demonstrated that IV and SC naloxone administration appeared to be equally effective in returning patients suffering from opioid overdose to spontaneous breathing. However, we advised the physician that the study was subject to a number of biases, including the utilisation of historical controls, a lack of clear randomisation, and the recruitment of fewer patients (74) than the 92 required to achieve 90% power. The physician used the information from our report to change the emergency department's policy — the use of IV naloxone was eliminated to reduce the risk of needle-stick injury to staff.

Jason Wasiak MPH · Ornella Clavisi BSc(Hons) MPH

Case reports Case 1: A 22-year-old man complained that he was "burning up" and collapsed after ingesting drugs at a friend's house. He died soon afterwards at a local hospital, despite attempts at resuscitation. His core temperature was 42oC. At autopsy there was evidence of coagulopathy, with scattered bruises, intra-alveolar haemorrhage, and haemorrhagic pleural effusions, ascites and stomach contents. Toxicological blood analysis revealed a lethal level of PMA (1.3 mg/L), together with 0.02 mg/L of MDMA and 0.21 mg/L of methylamphetamine. No alcohol was detected in the blood. Case 2: An 18-year-old man died at his home after ingesting a number of "ecstasy" tablets over five hours, both at a dance club and at home. Two hours after death the core temperature of the body was 39oC. Autopsy revealed focal pericardial haemorrhage, pulmonary congestion and renal tubular necrosis. Toxicological blood analysis showed a lethal level of PMA (1.7 mg/L), with 0.1 mg/L of MDMA and 0.06 mg/L of methylamphetamine. No alcohol was detected in the blood. Case 3: A 19-year-old man died in hospital 40 hours after being brought to the emergency department in respiratory arrest with a body core temperature of 41.6°C. He had taken "two or three capsules" of street drugs of an uncertain nature, both at a "rave" party and then at a friend's home the following day. According to witnesses, he had been advised to take PMA for an enhanced effect after taking MDMA. Laboratory investigations revealed evidence of rhabdomyolysis, with a serum myoglobin level of 328 960 g/L (normal level, < 150 g/L), disseminated intravascular coagulation and marked hyperkalaemia (7.7 mmol/L; normal range, 3.5–5.0 mmol/L). At autopsy there was evidence of coagulopathy, with epicardial petechiae, pulmonary haemorrhage, haemorrhagic gastric and intestinal contents, and haemorrhagic serous cavity effusions. There was also oedema and necrosis of skeletal muscle and renal tubular necrosis. Toxicological blood analysis revealed a lethal level of PMA (0.98 mg/L), with 0.32 mg/L of MDMA. No alcohol was detected in the blood. Analysis of capsules found with the patient revealed PMA with no other amphetamine derivatives. Death from amphetamine use is a well recognised occurrence, with most reported fatalities involving the use of 3,4-methylenedioxymethamphetamine (MDMA, or "ecstasy"). In 1998, a series of six cases of death due to an unusual amphetamine drug, paramethoxyamphetamine (PMA), was reported in South Australia.1 The only other comparable report of deaths due to PMA was that of nine deaths in Ontario, Canada, in the early 1970s.2 In 1998, our group warned that, although PMA substitution for MDMA appeared at the time to be a local Australian problem, there was a possibility that the manufacture and sale of PMA could occur in other countries. Unfortunately, this prediction has been proved accurate, with recent reports of PMA-related deaths in the United States, Europe and Canada.3-5 Initially, it was assumed that PMA was created as a contaminant during the synthesis of MDMA and was being disguised and substituted for MDMA by local dealers attempting to offload the drug.1,6,7 However, this is now considered unlikely, as the chemical precursors of PMA and MDMA are different,3,4 and information received concerning Case 3 (described here) suggests that capsules containing only PMA are being marketed specifically to augment the effects of MDMA. This is an extremely dangerous development, as it is well recognised that PMA has a much greater propensity to produce adverse effects than other ring-derivative amphetamines.6 Death in each of the cases described here was due to PMA toxicity with hyperthermia. PMA levels of higher than 0.3 mg/L and MDMA levels higher than 0.6 mg/L have been found in cases where deaths were attributed to these drugs.1

Roger W Byard MD · Nicholas G Rodgers MB BS · Ross A James FRCPA · Chris Kostakis BSc(Hons) · Andrew M Camilleri BSc(Hons)

To the Editor: The Australian Defence Force (ADF) has sustained many cases of malaria following service in East Timor.1 To reliably prevent relapse of malaria caused by the Chesson strain of Plasmodium vivax present in this region, larger doses of primaquine are required2 (up to 6 mg/kg total dose,3 compared with > 3.5 mg/kg to prevent relapse of sub-Saharan vivax malaria4). The ADF uses 1500 mg chloroquine (total base) followed by 315 mg primaquine (total base) for the treatment of vivax malaria, which, in Australia, is commonly treated either without primaquine or with inadequate dosages of either chloroquine or primaquine.5 A fit, 65 kg male soldier who deployed to East Timor from October 1999 to May 2000 experienced one episode of vivax malaria during his deployment and a further four episodes on return to Australia (Box). Having had malaria in East Timor, he complied closely with postexposure prophylaxis with primaquine and tolerated his dose (7.5 mg three times daily with meals) well for the required 14 days (315 mg total). He was seronegative for HIV, hepatitis C, and dengue IgG and IgM, and was not glucose-6-phosphate dehydrogenase deficient. The Table shows that our patient had a parasite that was apparently responsive to chloroquine, although it did not respond as readily in the last episode. In his first episodes of malaria on return from East Timor, he received the recommended dose of primaquine, but developed recurrences in the absence of further exposure to malaria. These relapses presumably indicate an inadequate response to the primaquine. The total dose of primaquine used for postexposure prophylaxis and treatment of the first episodes in Australia was about 4.8 mg/kg. He has subsequently received a treatment of 6 mg/kg total primaquine (see Table, Episode 5). This follows extended suppression with chloroquine before and doxycycline during a three-month deployment to Malaysia. There has been no further relapse six months after treatment. Chesson-strain vivax malaria is known to be difficult to treat and in which to prevent further relapse. Adequate primaquine to treat vivax malaria from other areas is not adequate for that contracted to the immediate north of Australia. Relapsing vivax malaria from East Timor may require a dose of 6 mg/kg of primaquine to prevent further relapse. Parasite density and treatment during the patient's episodes of malaria Episode Date of diagnosis Parasite density Treatment 1 1 April 2000 Positive on immunochromatographic test* Chloroquine 1500 mg, continued doxycycline 100 mg daily, primaquine 315 mg from 2 May 2 17 July 2000 23 000/µL Chloroquine 1500 mg, then primaquine 315 mg 20 July 2000 No parasites seen 3 26 Sep. 2000 8607/µL Chloroquine 1500 mg, then primaquine 315 mg 29 Sep. 2000 No parasites seen 4 11 Dec. 2000 11 400/µL Chloroquine 1500 mg, then weekly for two months† 14 Dec. 2000 No parasites seen 5 3 April 2001 Occasional trophozoites on thick and thin film Chloroquine 1500 mg, then weekly for one month; doxycycline for three months, then primaquine 420 mg 6 April 2001 Occasional trophozoites only on thick film * Immunochromatographic test used in the field. † Patient ceased treatment.

Scott J Kitchener · Isaac Seidl

To the Editor: Hall et al1 argue that a hydromorphone trial would break the current deadlock in Australia over prescription heroin research. But would it? If hydromorphone was demonstrated to be an effective intervention for treating refractory heroin users, researchers would then wish to compare both hydromorphone and prescription heroin against the gold standard, oral methadone. The Prime Minister has stated publicly that proceeding with a prescription heroin trial "would send a wrong message". This claim is still unsupported by evidence. Clinicians and researchers should steadfastly oppose political interference in medical research from however august a level, especially when there is such a strong rationale for the trial and when researchers have so scrupulously followed scientific process. Such interference would not be tolerated in other areas of medical research and should not be tolerated in this field. The results of a recent large randomised controlled trial2 of prescription heroin in the Netherlands, while yet to be published in a peer-reviewed journal, provide strong additional support for an Australian trial. In contrast, Hall et al1 cite no previous evaluation of the efficacy of hydromorphone in managing heroin dependence. In Switzerland, prescription heroin is reserved strictly for treating refractory patients and accounts for fewer than 5% of all treatment provided.3 The importance of attracting and retaining this group in treatment is probably far greater than their small numbers might suggest, as there is reason to believe that they contribute disproportionately to the immense social costs of heroin use in the community. (By analogy, the heaviest-drinking 10% in a community account for half the total alcohol consumed.) Those who inject heroin very much more frequently than the community mean are probably responsible for a disproportionate share of crime and enlisting new recruits. Prescription heroin was selected as the experimental intervention in studies in Switzerland, the Netherlands, Germany and Spain and is now being considered seriously in Canada. The reasons advanced by Hall et al1 are all cogent arguments for conducting a trial of hydromorphone additional to an evaluation of prescription heroin. Hall et al are concerned about lack of community support for a heroin trial in Australia, but in a recent national opinion poll4 45% of respondents expressed support, while 47% were opposed. The case for an Australian heroin trial, with or without additional trials, remains compelling.

Alex D Wodak FRACP · Alison J Ritter PhD · Charles RR Watson PhD

To the Editor: We were disappointed with the article by Bailie and Runcie on household infrastructure in Aboriginal communities.1 It has major methodological and ethical problems that, in our view, should have precluded its publication. The data were not collected by a process which allows meaningful scientific analysis. In determining the state of health hardware, the authors did not outline the testing methods or how functioning of different items was assessed. No standardised procedure is evident within the process, no formalised training of those conducting the assessment is indicated, and there is no evidence that supervision or auditing of consistency was performed. In fact, these problems are acknowledged by the authors in a publication on the same project, in which they state: "There was no protocol for a number of steps in the data collection process. There was no protocol for what type of information was gathered by interviewing residents, nor for which resident was the most appropriate interviewee. "The way data was collected varied between field officers, and the way an individual officer collected data varied between houses. Firstly, the items might be observed. Secondly, but not always, items may be tested for functionality (eg, by turning a tap on). Whether items were physically tested sometimes depended on how "clean" the house was. If it was clean, then the items were sometimes assumed to be functioning . . .".2 No amount of analysis can correct for such inadequacy in primary data. The authors dismiss this problem by referring to consistent patterns of data across different communities. This in no way addresses the problem of identifying the true level of hardware functioning. It simply suggests that measurement omission or error was widespread. Even if the items tested did not require maintenance, this does not indicate that they were functioning adequately, as no defined and standardised tests were applied (see Appendix B, page 38, in reference 2).2 The article's ethical problems are masked by discussion about community confidentiality. The authors described an audit and assessment of health hardware without any attempt at intervention and improvement. This is in a setting where a method that links assessment and intervention has not only been established, but is now performed by different groups across a wide range of communities. In fact, this process is referenced by the authors.3 The article by Bailie and Runcie reinforces what is widely known — that Aboriginal housing is generally poor. There can be only two reasons for trying to assess the actual state of Aboriginal housing and health hardware. The first is to enable intervention to rectify the problem at the same time. The second is to enable future housing and infrastructure programs conducted by government to be technically targeted and subsequently assessed to determine whether improvement really is occurring. Unless the baseline status is accurately and reproducibly determined, then we will have no way of knowing whether such programs are actually making a difference.

Paul J Torzillo · Paul Pholeros

In reply: A primary objective of our evaluation1 was to identify methodological deficiencies for the purpose of improving data quality in subsequent surveys. These deficiencies, described in detail in our evaluation report and referred to by Torzillo and Pholeros, are also described in our Medical Journal of Australia article.2 Our assessment (reinforced by reference to subsequent survey findings) was that the data were of sufficient quality to be useful for the purpose for which they were collected — to guide and monitor a substantial maintenance and building program. Torzillo and Pholeros appear to have missed this point. Their analogy with a clinical therapeutic trial where the survey is equated with a placebo is absurd, all the more so for the reference to the HealthHabitat work as being "an effective agent [that] is already licensed". This "effective agent" has, to my knowledge, never been subjected to external evaluation or peer review — some licensing process! With regard to ethics, a fundamental aim of the survey was to identify areas of greatest need, and allow the allocation of resources on an equitable basis to improve Aboriginal housing standards across the Northern Territory. In an environment of massive need and limited resources, this is arguably a more ethical approach than that of HealthHabitat, where, in 2001, intensive input was delivered to only four out of hundreds of Aboriginal communities in the NT. Runcie M, Bailie R. Evaluation of environmental health survey data – Indigenous housing. Darwin, Northern Territory: Menzies School of Health Research, July 2000. Bailie RS, Runcie MJ. Household infrastructure in Aboriginal communities and the implications for health improvement. Med J Aust 2001; 175: 363-366. <eMJA Full text> <PubMed> (Received 21 Mar, accepted 25 Mar 2002)

Ross S Bailie

To the Editor: Cunningham has shown that in Australian public hospitals patients identified as Indigenous are significantly less likely than other patients to have a principal procedure recorded.1 This finding is based on data collected by the Australian Institute of Health and Welfare using the coding scheme of the International classification of diseases, 9th revision, clinical modification (ICD-9-CM). No information was available about the clinical indications for conducting a principal procedure. Despite this crucial omission, Cunningham speculates about the reasons for the disparity in the rate of procedures between Indigenous and non-Indigenous patients. These speculations include alarming suggestions such as the possibility of systematic discrimination against Indigenous patients of both an institutional and personal nature. She then concludes that "Work is urgently needed to characterise more fully the nature, level, sources and consequences of institutional and interpersonal discrimination so that we can reduce unfair treatment, ensure equitable care and improve outcomes for the most disadvantaged Australians". These speculations and conclusions are simply unjustified by the data. In addition, such comments may cause more harm than good — Indigenous people have become extremely sensitive about medical and social research and may reject future investigations that are essential to their welfare. There are reasons other than adverse discrimination which may explain the data. These include the common rejection by Indigenous patients of medical advice to have a procedure (they may well be adopting the wisest action), and their more frequent admission to hospital (rather than outpatient care), as they may have travelled from remote communities (ie, there are social criteria for admission without the need for medical procedures). Furthermore, the quality of the data must be questioned, as many Indigenous patients are admitted to hospitals where the data forms are completed by unskilled personnel who do not understand the meaning of a "principal procedure". Cunningham J. Diagnostic and therapeutic procedures among Australian hospital patients identified as Indigenous. Med J Aust 2002; 176: 58-62. <eMJA Full text> <PubMed> (Received 1 Mar 2002, accepted 25 Mar 2002)

James S Lawson

In reply: Lawson suggests that my conclusions1 are not justified, and that they may "cause more harm than good". I strongly disagree. He suggests a number of alternative explanations, including "social" admissions for remote patients, and poor coding, but these do not account for the differences observed. Over half of the separations identified as Indigenous were of urban (19%) or rural (33%), rather than remote, area residents. Disparities in procedures for Indigenous and other patients were evident for each area. Almost half (46%) the separations identified as Indigenous were in principal referral or major hospitals, where coding should be of a high standard. Indigenous–non-Indigenous disparities existed within each hospital category. The results presented in my report1 were adjusted for area of residence, hospital category, as well as several other factors, and large differences in procedures remained. Lawson also suggests that rejection of medical advice by Indigenous patients may play an important role. Rejection of advice certainly occurs on occasion, by both Indigenous and non-Indigenous patients. I question whether it is "common", as Lawson suggests, but that is not really the point. It would be far more productive to ask why and how this occurs, and how interactions between healthcare providers and Indigenous patients can be improved. Lawson takes exception to my raising the possibility of systematic discrimination in the Australian healthcare system, referring to it as "alarming". In that we are in complete agreement. I, too, find it alarming. However, unlike Lawson, I choose not to deny it, but to accept it as an important challenge. My aim is not to make medical practitioners defensive, but to invite them to participate in finding ways to reduce disparities. Systematic discrimination can occur even when well-meaning people are trying to do the right thing. The systems in which we work can defeat our best intentions, even when we don't realise it. The reasons why a procedure was not performed on a particular patient may be perfectly sound given the circumstances. What we must ask ourselves is how those circumstances came to be, and what we can do to change them. I agree with Lawson that some Indigenous people are sensitive about research, but I do not accept that they will "reject future investigations that are essential to their welfare". On the contrary, I expect that many Indigenous people would be happy to participate with healthcare providers in the development and implementation of creative solutions to improve the healthcare system. Cunningham J. Diagnostic and therapeutic procedures among Australian hospital patients identified as Indigenous. Med J Aust 2002; 176: 58-62. <eMJA full text> <PubMed> (Received 21 Mar 2002, accepted 25 Mar 2002)

Joan Cunningham

To the Editor: It is possible to diminish bias, especially in litigation concerning general practitioners.1 First, request all the defendant's clinical notes about the patient, not merely the records of the incident. Then, before reading the allegations or the history following the incident, read the entire history of the patient's contacts with the doctor or the practice: frequency of attendances, nature of complaints, details of history and examination, referrals for tests or second opinions — all give insight into the nature of that patient–doctor relationship. Reading the notes from the beginning allows the expert to approach, anterospectively, the consultation(s) at which things went awry. If the relevant consultation cannot be identified, the expert has to correlate the patient's story, as presented by the solicitor, with the doctor's records. As he or she progresses through the records, the expert can assess whether or not the doctor's recorded acts accorded with responsible practice. Unrecorded omissions can also be identified, based on what is written in the records: why didn't the doctor ask about X, examine for Y, request a test for Z or refer to a specialist? Of course, these things might have been done, but not recorded. One would hope that barristers for both parties would frame their questions based on a similarly anterospective approach, and that judges would focus their attention and that of a jury (if there is one) on the appropriateness of process rather than on the unfortunate outcome. I cannot conclude without mentioning one solicitor's claim that the doctor had failed to use a retrospectoscope. Competing interests: P C A, at the request of both plaintiffs and defendants, provides expert opinions for the courts. Hugh TB, Tracy GD. Hindsight bias in medicolegal expert reports. Med J Aust 2002; 176: 277-278. <eMJA Full text> <PubMed> (Received 19 Mar 2002, accepted 11 Apr 2002)

Peter C Arnold

To the Editor: I read with interest the recent article by Hugh and Tracy on hindsight bias in medicolegal expert reports.1 As they themselves admit, "the very seeking of an expert opinion usually indicates that there has been an adverse outcome". In my experience, the unfortunate outcome can usually be predicted within reading the first few paragraphs of the brief. I do not think withholding information on outcome would prevent the occasional use of the "retrospectoscope". I wondered whether the views of the authors might have been slightly biased on the basis of the particular cases they had reviewed as Chairmen of the Australian Cases Committee of the Medical Defence Union. Did these cases range across all specialties and subspecialties? The problem of hindsight bias is, in my view, greater when there are no clearly accepted guidelines for diagnosis and management, or where the case is unusual and falls outside the exposure of experienced clinicians. They mention clinical practice guidelines as a way to improve the objectivity of experts, but then seem to exclude them on the basis of the expense and time involved in their development. In cardiology, there are now internationally accepted guidelines developed by the American College of Cardiology and the American Heart Association for the diagnosis and management of all common clinical situations.2 These are regularly updated and have been sometimes modified for Australian use by the Quality of Health Care Committee of the National Health and Medical Research Council (NHMRC) or the Cardiac Society of Australia and New Zealand.3 These guidelines provide an important baseline for any expert opinion in this specialty. More universal clinical guidelines will educate reviewers. It will reduce the problems of hindsight and the overzealous expert. It will also allow the expert to be tested by the well-prepared barrister. Human nature being fallible, it will not eliminate personal bias. Hugh TB, Tracy GD. Hindsight bias in medicolegal expert reports. Med J Aust 2002; 176: 277-278. <eMJA full text> <PubMed> American College of Cardiology/American Heart Association guidelines for the evaluation and management of chronic heart failure in the adult: executive summary. Circulation 2001; 104: 2996-3007. <PubMed> Clinical exercise stress testing. Safety and performance guidelines. The Cardiac Society of Australia and New Zealand. Med J Aust 1996; 164: 282-284. <PubMed> (Received 19 Mar 2002, accepted 11 Apr 2002)

John B Hickie

In reply: We agree with Arnold that, ideally, expert witnesses should attempt to assess management decisions before acquainting themselves with the outcome and allegations in negligence cases. In practice, we suspect this is rarely done. In any case, the mere seeking of an expert opinion conveys the information that there has been an adverse outcome and, as we noted, there is evidence that, even if experts attempt to guard against it, hindsight bias is unavoidable in such circumstances. The central problem is that the expert is, as it were, looking back down one fork in the pathway of events, whereas the treating doctor was looking forwards at many possible and often uncertain forks.1 Hickie's statement "in my experience the unfortunate outcome can usually be predicted within reading the first few paragraphs of the brief" epitomises the very problem we address. Such retrospective snap judgements are characteristic of hindsight bias and are often accompanied by the telltale phrase, known to be a marker for hindsight bias,1 "it should have been obvious". We are unable to understand Hickie's statement that our "views . . . might have been slightly biased on the basis of . . . cases . . . reviewed as Chairmen of the Australian Cases Committee of the Medical Defence Union". The Committee contained representatives from the major specialties, including two consultant physicians, and the cases ranged over all specialties and subspecialties. Experts from subspecialties, including cardiology, were co-opted when appropriate. We agree with Hickie that clinical practice guidelines are useful. We did not recommend that they be excluded, but we did draw attention to their difficulties and limitations. We acknowledge the admirable work done by the American College of Cardiology in developing an impressive range of guidelines, but our view remains unaltered that they are costly in terms of time and effort to produce, cannot cover all clinical contingencies, and have limitations when applied to negligence cases. The guidelines for heart failure referred to by Hickie took more than three years to prepare, involved numerous committee members and no fewer than 26 reviewers, and were not subsequently updated for six years. Relatively few guidelines have been modified for Australian use and some are obviously deficient. For example, the current National Health and Medical Research Council (NHMRC) guidelines relating to the common problem of chest pain2 are six years old, and have been criticised on the grounds that they have not been rigorously tested to ensure clinical usefulness and do not include appropriate management strategies for patients with non-cardiac chest pain.3 We adhere to our view that these problems make it likely that clinical practice guidelines will have a limited role in negligence cases. Cook RI, Woods DD. Operating at the sharp end: the complexity of human error. In: Bogner MS, editor. Human error in medicine. New Jersey: Lawrence Erlbaum, 1994; 255-310. Working party of the NHMRC Standing Committee on quality of care and health outcomes. Clinical practice guidelines: diagnosis and management of unstable angina. Canberra: National Health and Medical Research Council, 1996. Eslick GD, Talley NJ. Non-cardiac chest pain: squeezing the life out of the Australian healthcare system? Med J Aust 2000; 173: 233-234. <PubMed> (Received 9 Apr 2002, accepted 11 Apr 2002)

Thomas B Hugh · G Douglas Tracy

To the Editor: Comments made by Parker et al1 in response to Leeder and Rychetnik's article on evidence-based medicine (EBM)2 do not reflect the reality of the dilemmas clinicians face in practice — arguably, because of political misuse of the concept of EBM, which Leeder and Rychetnik warned against. Parker et al take issue with the "worry that EBM might be misused in public policy . . . where evidence is difficult to obtain", and argue that this is not the case. However, the previous Health Minister, Dr Wooldridge, was a great admirer of the Cochrane Collaboration, and, based on a perceived lack of evidence, he cut Medicare rebates in 1996 (by 50%) for patients needing long-term intensive psychiatric outpatient treatment. Although, after much protest, this decision was amended somewhat, Item 319 of the Medical Benefits Schedule remains today as a stark reminder of how some patients cannot access fully the treatment they desperately need. There is abundant evidence (international and local) as to the efficacy of this form of intensive treatment.3 There is also abundant and clear evidence that all who seek this treatment are traumatised by previous failed shorter treatments, often have comorbid disorders, and have established DSM-IV diagnoses of long standing.4 All this evidence was made available to the Minister — but Item 319 remains, with its exclusionary and discriminatory criteria to ration access, in my opinion due in large part to political misuse of the concept of EBM. Contrary to the assertion of Parker et al, there is a great deal to worry about. In addition, Parker and colleagues make the claim that mental health is attracting government attention and funding. Again, in reality, a great deal of money is being spent on promoting education and awareness — and certain kinds of treatment. There is no evidence that short-term treatments (which are heavily promoted) actually help the group excluded by Item 319 regulations. Yet public policy is being pushed along the lines of "one size fits all". It does not. All this is evidence of misuse of the idea of EBM reflected in public policy, and patients are suffering as a result. To make matters worse, cuts in one area are mindlessly used to push agendas that in clinical reality will be unworkable in other areas — all of which devalues professional expertise and judgement. Parker MH, Del Mar CB, Glasziou PP. Ethics and evidence-based medicine [letter]. Med J Aust 2001; 176: 138. <eMJA full text> Leeder SR, Rychetnik L. Ethics and evidence-based medicine. Med J Aust 2001; 175: 161-164. <PubMed> Doidge N. In: Cameron PM, Ennis J, Deadman JC, editors. Standards and guidelines for the psychotherapies. Toronto: University of Toronto Press, 1998. Doidge N, Simon B, Gillies LA, Ruskin R. Characteristics of psychoanalytic patients under a nationalised health plan: DSM-III-R diagnoses, previous treatment and childhood trauma. Am J Psych 1994; 151: 586-590. (Received 7 Feb 2002, accepted 25 Mar 2002)

Gil M Anaf

In reply: Anaf seems to have missed our point that the choice by Leeder and Rychetnik1 of mental health as an area relatively devoid of good quality evidence was a poor one — quality research has revealed mental health as an area of considerable need, and mental illness as a significant component of the global burden of disease. Despite the fact that evidence is often more difficult to obtain within the mental health area, much evidence exists — for example, the Cochrane Collaboration Depression, Anxiety and Neurosis Group has 11 500 controlled trials in its registry, and the Drugs and Alcohol Group has 3314. Anaf would agree with us here (on the basis of his assertions about the quality of the particular evidence he alludes to). On the narrower issue of the evidence base for long-term intensive psychiatric treatment, Anaf implies that this was ignored or distorted by the then Health Minister in deciding to amend the Medicare Benefits Schedule. We agree that EBM (and sound research) can be politically misused (as can any product of science), but that is no basis for rejecting EBM. Political misuse is a political mischief, not a failing in the particular instrument being misused. EBM itself is frequently blamed for all sorts of problems in health service, whereas, to use Anaf's example, the relative quality of the evidence for short or long term psychiatric treatment is a contingent matter for development and deliberation within and outside the psychiatric research community. Leeder SR, Rychetnik L. Ethics and evidence-based medicine. Med J Aust 2001; 175: 161-164. <PubMed> (Received 22 Mar 2002, accepted 25 Mar 2002)

Malcolm H Parker · Chris B Del Mar · Paul P Glasziou

To the Editor: I wish to commend the Journal for publishing the article by Cunningham1 and the analysis of her findings in the accompanying editorial.2 Both articles stress the need for improved communication between Indigenous patients and hospital staff. The Kimberley Interpreting Service provides accredited Aboriginal language interpreters for six Kimberley languages, and is involved in training other interpreter candidates. We have been operating since November 2000 and are currently looking for funding to continue offering our service into the future. To date, we have been working primarily in the legal sector and are quite perplexed as to why we do not receive bookings from the health services. In 2002, the Kimberley Interpreting Service is targeting the health sector through a number of strategies, including the production of a promotional poster for use in hospitals and clinics, articles in medical publications, and face-to-face meetings with health professionals. I encourage your readers to find out more about our service and to pass the message on to colleagues. We can be contacted at kisATwn.com.au, or please visit our website at http://members.westnet.com.au/mirima/

Tea C Dietterich

To the Editor: The Australian Red Cross Blood Service (ARCBS) introduced a national policy for therapeutic venesection in December 1999 which allows the collection of blood from people with haemochromatosis. There is no charge for this service. The policy outlines the principles under which ARCBS provides a therapeutic venesection service, conditions of management of the donors and the acceptability of the donations for clinical use.1 These conditions are: The patient's condition benefits from regular venesection and the patient does not have a transfusion-transmissible disease. The blood donation will be used in clinical or derivative products only if the donors fully meet the donor selection guidelines for clinical use. Responsibility for patient management remains with the referring physician. ARCBS is responsible for the collection and for ensuring donor safety during the procedure. We will liaise with referring physicians about the venesection protocol if necessary, and reserve the right to refuse to venesect if there is a concern for donor safety. A diagnosis of hereditary haemochromatosis (evidence of iron overload together with appropriate genetic studies2) is required before patients are accepted into the therapeutic venesection program. Contact your local ARCBS for copies of the therapeutic request form. Completion of this will facilitate the entry of people to the ARCBS therapeutic program. The full policy can be obtained from our website <www.arcbs.redcross.org.au>.

Margaret L Buring

John St George was born in Malaya on 2 December 1924. His family returned to Ceylon in 1925, where he studied at St Patrick's College in Jaffna. In 1950, he graduated with Honours in medicine from the University of Ceylon in Colombo. Between 1957 and 1959, John worked with Professor T Jeffcoate at the University of Liverpool, UK, then with Dr P Myerscough at the Eastern General Hospital, Edinburgh. He was accepted as a Member of the Royal College of Obstetricians and Gynaecologists (1958) and a Fellow of the Royal College of Surgeons (1959), the International College of Surgeons (1968), and the Royal College of Obstetricians and Gynaecologists (1970). After working as a Consultant in Obstetrics and Gynaecology for the Government of Ceylon from 1959 to 1964, John spent a number of years (1964–1967 and 1972–1975) as Chief Consultant in Obstetrics and Gynaecology for the government of northern Nigeria. It was there that he perfected his technique of vesicovaginal fistula repair. These fistulae, which are relatively common among rural women, arise from obstructed labour or from application of potassium permanganate by "bush doctors" (local herbalists). While in Nigeria, John initiated the obstetric "flying squad" to enable women in remote areas to receive emergency medical treatment, and helped to invent a two-wheel collapsible trolley for bush track roads to help reduce maternal mortality. In 1974, the London School of Hygiene and Tropical Medicine awarded him the Langley Memorial Prize for this work. In 1975, John migrated to Australia and set up practice at Burwood and Lakemba, in Sydney, working as a gynaecologist at the Western Suburbs Hospital until 1993. He retired in 1998. John was passionately interested in sports and the Church. From his early years at St Patrick's College, where he was the captain of both the athletics and soccer teams, he took to heart the College's motto "fide et labore" (faith and work). He based his entire life on this simple yet profound philosophy, which saw him succeed in his career and adapt to many different cultures and countries with ease. John died peacefully (of hypostatic pneumonia) at Concord Hospital on 9 December 2001, at the age of 77.

Lourdes I St George LRCPS FRCOG FRACOG

Australia lost one of its eminent academic surgeons when John McCaffrey died of cancer on 4 November 2000. Ironically, as an oncological surgeon he had treated many grateful cancer patients during his long and distinguished career in south-east Queensland. John was born on 31 January 1933 and educated in Brisbane at St Lawrence's College, where he was school captain, school dux and captain of athletics. He graduated from medical school at the University of Queensland in 1956 with first class honours and also received the University Medal for Outstanding Merit, the Nathanial Robertson Medal in Medicine, and the H G Wilson Prize. John started his medical career in 1957 at Brisbane's Mater Hospital, where he met and later married physiotherapist Denise Moroney. He completed a Master of Surgery in 1961 and became a Fellow of the Royal Australasian College of Surgeons in 1962. In the same year he won the prestigious Nuffield Travelling Fellowship, which he took up at the University Department of Surgery in Glasgow, where he remained for two and a half years and passed his Fellowship of the Royal College of Surgeons. Returning to Brisbane in 1964, he was offered the post of Senior Lecturer in Surgery at the Royal Brisbane Hospital and was promoted to Associate Professor in Surgery in 1969 at the Greenslopes Repatriation Hospital. In 1985, he was appointed Mayne Professor of Surgery, University of Queensland at the Royal Brisbane Hospital, a position he held until his retirement in 1989. John not only demonstrated a tremendous intellect, but also displayed great compassion for his patients and an excellent rapport with his students. He undertook a substantial body of clinical and scientific research in the course of his career and made an enormous contribution to surgical knowledge. He published over 100 scientific publications and was the author of numerous book chapters and many films and video clips. He had a vast number of international surgical contacts and was well known professionally in the United Kingdom, Europe, the United States and Canada, as well as many countries in Asia, particularly Vietnam. He was a founding member and eventually President of the Australian Society of Ultrasound in Medicine. He had a long association with the Queensland Cancer Fund (QCF) and was Chairman of its Medical and Scientific Advisory Committee from 1985 until the time of his death. His generosity of spirit was demonstrated by the enormous time he dedicated to the QCF with no financial reward. John was founder of the Breast Screening Clinic at the Royal Women's Hospital, Brisbane, which opened in 1985 as the first public breast screening service in Australia. Its operating principles were incorporated into an Australia-wide pilot study, on which the BreastScreen Australia program was eventually based. In the course of his career, John made a very substantial contribution to the development and progress of surgery and surgical oncology, both in Australia and internationally. In particular, he advanced the understanding and implementation of breast cancer screening and of the treatment of early breast cancer, and disseminated his knowledge as a dedicated teacher and researcher. He is survived by his children Anne-Marie, Elizabeth, Sean and Chris.

Ian C Bennett

As a result of the National Mental Health Strategy (1993–2003), the reform of Australian mental health services has come a long way.1 Specifically, issues highlighted by consumers and carers (increased access, commitment to equity, improved quality of services, promotion of choice and active participation by consumers and carers in national and local planning and decision-making) have been increasingly recognised. The time has now come to move from recognition of these issues to service changes that meet the identified needs, expectations, and standards of the wider community.2 The aim of consumer and carer participation is to improve the quality of service delivery and increase the level of consumer and carer satisfaction. The Mental Health Council of Australia, which is the peak, national, non-government organisation established to represent and promote the interests of the Australian mental health sector, has played a key role in the development of national policy on consumer and carer participation. Improved health outcomes are achieved when consumers and carers play an active role in decision-making and treatment programs and are given the opportunity to work in partnership with service providers in determining effective treatment options.3 It is no longer acceptable for healthcare professionals and policy makers to dismiss the input and deny the participation of consumers and carers in healthcare systems. Consumers and carers are entitled to access to equitable and quality healthcare services which offer choice and participation in selecting the most appropriate treatment options in the most empowering settings. The provision of effective and empowering healthcare services requires healthcare professionals to: foster an understanding of effective treatment options and treatment guidelines; be aware of how mental illness is perceived and experienced by the individual and the community; and ensure participation of, and provision of information to, people who experience mental illness and their carers. The material provided in this Supplement should assist practitioners in these tasks. Mental health services must aim to assist the individual back into active participation in community life by promoting independence and autonomy. Listening to what consumers and carers want from service delivery, taking account of what their needs are, and involving them in treatment and management plans is simply the starting point. If we are to move beyond "tokenism" to "a respected and affirmed role" for consumers and carers,2 then we need mental health service providers to be more informed, more engaged and more willing to enter active partnerships with people whose lives are affected daily by mental illness.

John F McGrath

General practitioners are usually the first point of contact for people with depressive illnesses. Their ongoing support, encouragement and, most importantly, provision of appropriate information is critical to the management of these illnesses. Patients generally respect and trust their doctor and will be guided by the GP's advice. Information is empowering. It allows people to make informed choices about their treatment and care. Initially, a patient suffering from a depressive illness may only need, or want, basic information about their illness. However, over time, the provision of more specific and detailed information for both the sufferer and his or her family is desired and appropriate. Unfortunately, doctors often assume that patients know more than they do about their illness. However, lack of knowledge about where to look, the stigma associated with depressive illnesses and the belief that they can somehow "pull themselves together" may dissuade many people with depression from directly asking the GP for information. Even the most proactive patients can become disheartened at the lack of general information about depressive illnesses available to the community. GPs have taken on the role of information providers, but now need to see this role in broader terms. Consumers and carers want information in the form of handouts, lists of appropriate books and articles, website addresses, support group details and other available resources. It is also important that the information presented to patients is relevant, easy to read, written for the target audience and not biased. The Internet is extremely useful for accessing relevant information, but it is also a source of inappropriate information. Anyone can be an author about depressive illnesses on the Internet, writing only from their own point of view. For example, in a search on antidepressants, I found a website condemning their use, based only on the experiences of the writer.1 This sort of (mis)information can be confusing to patients and their families. Therefore, gentle guidance of patients to appropriate websites, in addition to other sources of appropriate information, is crucial. The information in this supplement will help GPs and other healthcare professionals in this task.

Lara M Bishop

Depression is a major public health issue in Australia.1 Although more than 800 000 Australians experience depression each year, less than 40% of affected individuals present for care and fewer than one in six receive an evidence-based treatment.1 Most people with depression experience significant disability (reduced productivity on "seven of the past 28 days"2) and those who present for care are likely to have relapsing or chronic disorders.3 The current health burden of depression, and the projected future impact on our society, prompted the Federal and Victorian governments to develop beyondblue: the national depression initiative.4 The initiative has bipartisan political support and has grown to include active participation by other States and Territories and the development of partnerships with a range of non-government and community-based organisations.5 The aim of beyondblue is to promote effective population health-based strategies.6 Current projects focus on: increasing community awareness of key aspects of depression (such as characteristic symptoms, risk factors, pathways to care, preventive and effective treatment strategies); promoting destigmatisation of people with depression and related disorders; confronting barriers that discourage full social participation; and advocating for improved primary-care-based mental health services. With regard to secondary services, the initiative is focused on improved specialist support for the primary care sector. To meet the specific needs of people with depression and their carers, beyondblue has initiated a range of studies, some of which are outlined in this Supplement, and promoted the rapid dissemination of results to the medical profession. The review by Jorm et al7 (page S84) of complementary and self-help therapies used for treating depression represents a landmark study. It departs from the traditional debate about access to strategies that people say they want (such as access to counselling8) and evidence about what professional services people actually receive (eg, medication and non-specific psychological support9), and presents a scientific, dispassionate appraisal of treatments that people often use. Elsewhere, the same authors have noted that people not only use such complementary therapies,8 but also prioritise the use of harmful substances such as alcohol. The report by Jorm et al7 and the community survey on how Australians perceive depression10 (page S63) highlight that the community does not see doctors as a critical part of the public health response to depression. This is due to the persistent view that mental health is, at best, a marginal health issue, in combination with a lack of knowledge about available services and treatments.10 Unfortunately, the experiences of consumers and carers11 (page S69) indicate that interactions with different levels of the healthcare system reinforce the belief that depression is not a major concern of healthcare providers. Furthermore, the ongoing stigma within the community has major negative effects on people with depression and their carers. This results in overt and covert barriers to social participation that continue even when these people have recovered. The lack of leadership by both primary care and specialist doctors in promoting destigmatisation is clear to people with depression who use our healthcare system. For beyondblue, the promotion of the direct voice of consumers and carers is critical to the process of destigmatisation and ongoing medical education. Given the lack of detailed knowledge about depression in the community,10,12,13 beyondblue needs to find new ways of providing authoritative information to people who have not sought care and to those who have, because, all too often, access does not lead to the receipt of sufficient information to make treatment or personal choices. Advances in information technology are often seen as one solution. The review of Australian depression websites by Griffiths and Christensen14 (page S97) is intended to assist doctors and other healthcare professionals in recommending websites to patients and their carers. It is also intended to encourage healthcare professionals, particularly in primary care, to promote the use of high-quality Internet sites. Finally, if consumers are to make informed choices, they require access to the most up-to-date syntheses of professional knowledge. Evidence-based guidelines can assist consumers to avoid treatments that do not work (or do more harm than good), that do not justify the personal or wider social cost, or that delay access to more effective treatments. beyondblue felt that it was essential to commission recommendations for the management of depression in primary care and that the key recommendations be made directly available to doctors and other primary care professionals (page S77).15 Over the life of the beyondblue initiative, it will be critical to continue to evaluate community recognition of depression, the impact of this recognition, and the extent and persistence of personal and social barriers to full social participation. The results presented here10,11 provide baseline data and underpin an agenda for promoting the concerns of consumers and carers.11 In turn, beyondblue hopes that these articles will promote a variety of new methods (including novel instruments for measuring consumer- and carer-based concepts of recovery and other illness outcomes), and the development of quality monitoring and outcome systems within our healthcare environment.16,17 beyondblue looks forward to reporting the outcomes of such endeavours in the near future.

Ian B Hickie MD, FRANZCP

Objectives: To determine the degree of recognition and understanding of depression and its treatments in Australia in 2001, and detail factors and personal experiences that influence awareness of and attitudes to depression.Design and setting: Cross-sectional survey of a representative community sample (900 randomly selected respondents), via telephone interview, conducted 5–7 October 2001.Main outcome measures: Reports of community awareness, knowledge and attitudes to depression and its treatments in Australia.Results: The Australian community does not view mental health as a major general health issue. When asked specifically, depression was recognised as the most common mental health problem. Recognition of depression was greater among women and younger people. Most people (58%; 508/879) reported that they or a family member had experienced depression. People younger than 55 years and people with personal or family experiences of depression viewed depression as more disabling than other chronic medical conditions. Half the respondents differentiated depression from normal sadness. Awareness of common risk versus protective factors was limited. Most people endorsed a preference for self-help and non-pharmacological treatments, but community views of antidepressant drugs were less negative than expected. General practitioners were identified as the preferred point of first contact among healthcare professionals.Conclusions: Although mental health is still not highlighted as a major health issue, Australians do recognise depression as the major mental health problem. Women and younger people have more substantial knowledge about key aspects of depression and its treatments.

Nicole J Highet DPsych · Ian B Hickie MD, FRANZCP · Tracey A Davenport BA(Hons)

Objectives: To describe the experiences of people whose lives have been affected by depression.Design, setting and participants: Thematic review of data collected from 21 community meetings (1529 people, providing 911 evaluation forms) and nine focus groups (69 individuals) held nationally, and written feedback and website-based interactions with beyondblue: the national depression initiative between April and December 2001.Main outcome measures: Barriers to social participation experienced by people whose lives have been affected by depression, and their interactions with the healthcare system.Results: The key theme was the experience of stigma, which was evident in healthcare settings and in barriers to social participation, particularly regarding employment. Inadequacies of primary care and specialist treatment systems were highlighted. Particular emphasis was placed on limited access to high-quality primary care and non-pharmacological care. The stigmatising attitudes of many healthcare providers were notable. Within society, lack of access to knowledge and self-care or mutual support services was evident. Lack of support both from and for people in caring roles was also emphasised.Conclusions: People with depression are subject to many of the same attitudes, inadequate healthcare and social barriers reported by people with psychotic disorders. Consumers and carers prioritise certain notions of illness, recovery and quality of healthcare, and expect healthcare providers to respond to these concerns.

Bernard G McNair RN, GradDipNursingMgmt · Nicole J Highet DPsych · Ian B Hickie MD, FRANZCP

Objectives: To review the evidence for the effectiveness of complementary and self-help treatments for depression.Data sources: Systematic literature search using PubMed, PsycLit, the Cochrane Library and previous review papers.Data synthesis: Thirty-seven treatments were identified and grouped under the categories of medicines, physical treatments, lifestyle, and dietary changes. We give a description of each treatment, the rationale behind the treatment, a review of studies on effectiveness, and the level of evidence for the effectiveness studies.Results: The treatments with the best evidence of effectiveness are St John's wort, exercise, bibliotherapy involving cognitive behaviour therapy and light therapy (for winter depression). There is some limited evidence to support the effectiveness of acupuncture, light therapy (for non-seasonal depression), massage therapy, negative air ionisation (for winter depression), relaxation therapy, S-adenosylmethionine, folate and yoga breathing exercises.Conclusion: Although none of the treatments reviewed is as well supported by evidence as standard treatments such as antidepressants and cognitive behaviour therapy, many warrant further research.

Anthony F Jorm PhD, DSc · Helen Christensen MPsychol, PhD · Kathleen M Griffiths BSc, PhD · Bryan Rodgers MA, PhD

Objectives: To provide information about Australian depression sites and the quality of their content; to identify possible indicators of the quality of site content; and determine the accessibility of Australian depression web sites.Design: Cross-sectional survey of 15 Australian depression web sites.Main outcome measures: (i) Quality of treatment content (concordance of site information with evidence-based guidelines, number of evidence-based treatments recommended, discussion of other relevant issues, subjective rating of treatment content); (ii) potential quality indicators (conformity with DISCERN criteria, citation of scientific evidence); (iii) accessibility (search engine rank).Results: Mean content quality scores were not high and site accessibility was poor. There was a consistent association between the quality-of-content measures and the DISCERN and scientific accountability scores. Search engine rank was not associated with content quality.Conclusions: The quality of information about depression on Australian websites could be improved. DISCERN may be a useful indicator of website quality, as may scientific accountability. The sites that received the highest quality-of-content ratings were beyondblue, BluePages, CRUfAD and InfraPsych.

Kathleen M Griffiths BSc(Hons), PhD · Helen Christensen PhD, MPsychol(Hons)

Clinical use of blood in medicine, obstetrics, paediatrics, surgery and anaesthesia, trauma and burns. Geneva: World Health Organization, 2001 (337 pp). ISBN 92 4 154538 0. This World Health Organization (WHO) publication is a result of collaboration between numerous experts from around the world. As the title suggests, the book is aimed at clinicians using blood products, and is not a specialised transfusion textbook. A pocket summary is also available (Clinical use of blood handbook. Geneva: World Health Organization, 2001; 219 pp. ISBN 92 4 15439 9), which contains the essential guidelines for transfusion practice. Being a WHO publication, the authors have had to ensure that the principles espoused are practical and can be implemented in a variety of settings depending on available resources. The book is well written, clearly set out and has excellent illustrations and summary boxes. It is easy to find specific subjects and “get to the meat” of an issue. The text is addressed to medical, nursing and scientific professionals and should be easily readable and understandable to all. This is a practical, procedure-oriented, “how to do” book, with introductory chapters on the principles of transfusion medicine and the basic physiology of blood. Each chapter has learning outcomes and exercises that direct the application of the theory and practice to individual circumstances. There are chapters dealing with replacement fluids, and the full range of blood products and their composition. The section covering the clinical procedures involved in getting the right product to the right patient at the right time, and potential adverse effects of transfusion, should be mandatory reading for all clinicians. The second half addresses each of the medical disciplines named in the title. All common indications for blood component therapy are addressed in theoretical and practical detail. Despite the enormous amount of material covered in its 337 pages (and the pocket summary) it does not suffer from the problems which bedevil some multiauthored works. It displays a uniformity of style, shows no repetition, and is relatively lightweight and readable. This is definitely not a book that should sit in the library collecting dust — it is a day-to-day manual for any professional involved in the provision and/or administration of blood and blood products. It is affordable, and readily accessible copies should be available in all clinical and laboratory settings. James IsbisterDepartment of Haematology Royal North Shore Hospital, St Leonards, NSW

James Isbister

Management of dementia. Simon Lovestone and Serge Gauthier. London: Martin Dunitz, 2001 (viii + 168 pp). ISBN 1 85317 739 3. Dementia has a huge impact on the lives of those who come in contact with it — sufferers, their families and their carers. This concise book offers health professionals working in the field help to confront the issues and meet the challenges they will encounter throughout the pathway of care. The areas covered in the book are diverse. They vary from practical management of behavioural disturbance to the current theories of disease modification. Each individual chapter contains a summary of the latest research, followed by case reports and practical advice drawn from personal experience. The reader is led to a rich list of references for further study. Unfortunately, the wide range of topics covered produces a somewhat disjointed layout. The book is aimed at a wide audience. The first chapter, on managing the newly diagnosed patient, begins with a discussion of the disclosure of the diagnosis to patient and carers. The salient issues are summarised, giving a sense of the ethical complexities confronted at this early stage of dementia care. Other chapters deal with behavioural, psychiatric and sleep disturbances, with practical points supported by evidence when available. Surprisingly, two chapters are dedicated to biomedical markers and the potential for disease modification. These are interesting but have little practical value at this stage. A large section of the book is allocated to reprinting assessment scales that may be useful in the multidisciplinary evaluation of patient and carers. The authors are well-recognised leaders in the field and have written extensively on dementia. The book is easy to read and is enhanced by their personal experiences in the management of their patients and carers. There is an underlying emphasis on quality care, support and communication. At about $67 this concise, up-to-date guide is reasonable value for money. Dina LoGiudicePhysician in Geriatric Medicine National Ageing Research Institute, Parkville, VIC

Dina LoGiudice

Evidence-based healthcare. How to make health policy and management decisions. 2nd ed. J A Muir Gray. Edinburgh: Churchill Livingstone, 2001 (xxxix + 444 pp). ISBN 0 443 06288 9. Muir Gray is an extraordinary man. He is Director of the Institute of Health Sciences at Oxford and the Project Director of the National Electronic Library for Health. He posits himself as the amanuensis of a very talented group of fellow travellers, and the benefits of his authorship are evident in the consistent style and integrity of argument presented in this book. Evidence-based healthcare is organised in three sections: finding and appraising evidence; developing the capacity for evidence-based decision making; and getting research into practice. It is written for those who make decisions about groups of patients in order to “improve the competence of health service decision makers and to strengthen the motivation of any health service decision maker to use scientific methods when making decisions”. Thus, it represents one man’s vision for evidence-based healthcare and is a source of illumination and support for would-be evidence-based decision-makers. It is clearly not aimed at novice clinicians attempting to familiarise themselves with the technical tasks of critical appraisal or electronic information-searching techniques. This is the companion volume to such instructional texts. This edition shows signs of “second edition spread”, having grown from 270 to 444 pages over four years. New chapters cover evidence-based public health, consultation, and introduce post-modernism to evidence-based health care. Anyone with an interest in getting health policy right, from a new Health Minister to a hospital CEO faced with the third reincarnation of a Health network, or a clinician unexpectedly elevated to the ranks of hospital management, could profitably delve into this text. It will help clinicians to appreciate a systems perspective and the requirements for successfully implementing change. Few will attempt to read it cover to cover. If there is to be a systematic approach to health services delivery in Australia it will be led by clinicians and managers who can appreciate and work through the issues which Muir Gray identifies and discusses with such clarity and insight. I know of no book like this and, having read it, I would like to know more of the author. Donald A CampbellDirector, Clinical Epidemiology and Health Services Evaluation Unit Royal Melbourne Hospital, VIC

Donald A Campbell

Plastic bread clips are a rare but potentially avoidable cause of gastrointestinal obstruction or perforation which can be fatal. Case 1: A 79-year-old woman presented with peritonitis thought to be the result of a perforated viscus. Her condition was too poor for immediate operative intervention, and despite supportive treatment she died the same day. At autopsy, ileal perforation was identified related to a firmly adherent plastic bread tag (Figure). Two adjacent foci of congestion and mucosal distortion 24 cm proximally suggested a prior clip attachment site. She had suffered from dementia and her meals were made by her husband, who was blind. Bread tag from the patient in Case 1, detached to reveal the site of ileal perforation. Scale is in centimetres. Case 2: An edentulous 82-year-old woman presented with a one-day history of abdominal pain. A laparotomy showed ileal perforation related to a bread tag attached to the mucosa. Postoperatively, she developed bronchopneumonia which proved fatal. Three months before presentation, she had suffered a less severe episode of abdominal pain which had resolved on conservative treatment from her general practitioner. In Australia most bread bags are sealed by hard plastic clips. These are cheap and convenient, enabling the bag to be resealed after use. However, some countries have withdrawn their use because of gastrointestinal problems after ingestion.1,2 Patients swallowing clips are typically elderly and edentulous. The clips tend to snag on the small bowel mucosa, which may obstruct, erode or perforate. Impaction in the oesophagus, stomach or colon has also been reported.3 The tags are generally not seen on plain x-ray2 and patients are often unaware that they have swallowed them. Because of the high risk of complications, early endoscopic removal is advocated.4 With an ageing population, the proportion of edentulous people is likely to rise, increasing the risk of foreign-body ingestion. Alternative plastic bag sealers are available, although some also present health hazards. For example, ileal perforation has been reported after swallowing a freezer bag tie containing a wire.5 Bread bag clips have recently been replaced with tape in the United Kingdom for safety reasons (A Bennett, Allied Bakeries Customer Services Representative, Allied Technical Centre, Maidenhead, Berkshire, UK, personal communication). Abandoning the use of hard plastic bread tags in Australia in favour of adhesive tape would counter this health hazard.

Trevor W Beer MB ChB, MRCPath

Rebore or restore? An RCT by the CADILLAC group (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) has found that stent implantation after acute myocardial infarction (AMI) results in lower rates of re-occlusion than percutaneous transluminal coronary angioplasty (PTCA). Patients whose symptoms of AMI had been present for 30 minutes to 12 hours, with ST-segment elevation or LBBB, and who met defined angiographic criteria, were randomised to undergo PTCA or stenting, with or without abciximab. Altogether, 2082 patients were randomised at 76 centres in Europe and America. Treatment also included aspirin, heparin, β-blockers and ACE inhibitors, with clopidogrel or ticlopidone if a stent was used. After six months, there were no differences between the groups in the rates of death, stroke, or re-infarction. However, rates of ischaemia-driven target-vessel revascularisation were significantly different (PTCA, 15.7%; PTCA with abciximab, 13.8%; stent, 8.3%; and stent with abciximab, 5.2%). N Engl J Med 2002; 346: 957-966 Losing the spark In a Dutch RCT, the cognitive outcome following first coronary artery bypass graft “off-pump” was not convincingly better than with cardiopulmonary bypass (CPB) surgery. A battery of 10 cognitive tests was performed before, then 3 and 12 months after, surgery by psychologists blinded to the treatment group. Cognitive decline was defined as a decrease in an individual’s performance of > 20% in at least three of 11 main variables drawn from the tests. At three months, 21% of 128 patients in the off-pump group and 29% of 120 patients in the CPB group showed cognitive decline (RR, 0.65; 95% CI, 0.36–1.17; P = 0.15). At 12 months, cognitive decline occurred in 30.8% of the off-pump group and 33.6% of the CPB group. JAMA 2002; 287:1405-1412 Spare parts A 25-year follow-up report from the Mayo Clinic confirms that the Charney total hip arthroplasty gave good service. Between 1969 and 1971, 2000 hips were replaced in 828 men and 861 women (1647 for osteoarthritis); 541 were placed in people who lived for at least 25 years after operation. Altogether, 296 hips were re-operated, including 151 for aseptic loosening. Being younger at the time of operation and male sex were associated with increased risk of aseptic loosening (OR for each 10-year increase in age was 0.5 [95% CI, 0.4–0.6; P < 0.001] and, for male sex, 2.7 [95% CI, 1.9–3.9; P <0.001]). J Bone Joint Surg Am 2002; 84A: 171-177 Full service A systematic review and meta-analysis has revealed that intensive follow-up after curative resection for colorectal cancer improves survival. Using data from five RCTs, the British group found that, after five years, 197 of 666 patients (30%) randomised to intensive follow-up had died, compared with 247 of 676 patients (37%) in the control groups. The survival benefit was pronounced in the four trials that sought recurrence beyond the colon, using regular computed tomography and/or frequent measurements of serum carcinoembryonic antigen (risk ratio, 0.73 [95% CI, 0.60–0.89; P = 0.002]). There were no differences in rates of recurrence; however, these were detected significantly earlier in the intensive follow-up group (difference in means, 8.5 months (95% CI, 7.6–9.4; P < 0.001]). This suggests that the improved survival was owing to earlier detection of recurrences. BMJ 2002; 234: 1-8 Road testing After the first year of an Australian audit to evaluate endoluminal graft (ELG) for abdominal aortic aneurysm, 474 ELG patients could be compared with 356 patients treated with open repair. The Australian Safety and Efficacy Register for New Interventional Procedures – Surgical (ASERNIP-S) notes that death occurred in six of the ELG group and nine of the open group within 30 days of surgery; subsequently, there were five and seven deaths, respectively. The rate of procedural complications was 15% in both groups, but the percentage of systemic complications was higher following open repair. In an attempt to reduce bias, the open group were compared with a subgroup of ELG patients (n = 252) deemed by their surgeons to be suitable for open repair. There was no statistically significant difference in mortality, nor evidence that the complication rate was higher. It remains unclear whether Australian surgeons and patients will be willing to participate in an RCT. A N Z J Surg 2002; 72: 190-195