Volume 177 Issue 5

Improving glycaemic control in children and adolescents presents unique problems Type 1 diabetes affects one in 500 children and adolescents, and vascular complications remain a major cause of mortality and morbidity in adult life. Blood glucose targets have fallen since confirmation of the unequivocal relationship between glycaemic control and microvascular complications.1,2 In this issue of the Journal (page 235), Craig et al present a population-based, cross-sectional study of 1190 children and adolescents with type 1 diabetes in New South Wales and the Australian Capital Territory.3 Their median HbA1c level of 8.2% probably reflects some selection bias, because 571 (33%) of the population did not participate. However, this level of glycaemic control still represents a considerable improvement over the past 10 years4 and is comparable to levels found in international studies of children with type 1 diabetes.5 This trend accompanies the increasing use of intensive management in children and adolescents, but also the worrying rise in the incidence of severe hypoglycaemia. There are compelling reasons to recommend intensive therapy in adolescents with type 1 diabetes — either multiple daily injections or continuous subcutaneous insulin infusion. The effectiveness of intensive therapy in improving and maintaining good glycaemic control is well established in adolescents under research trial conditions.6 More recent data also indicate that the benefits of intensive therapy and improved glycaemic control persist even when HbA1c levels later rise.7 After completion of the Diabetes Control and Complications Trial (DCCT), adolescents from the former intensive therapy and conventional therapy groups returned to routine care and were advised to use intensive therapy. Despite no difference in their glycaemic control for four years after the end of the DCCT, the benefits of previous better control in the intensive therapy group persisted. Their prevalence of progression to proliferative or severe non-proliferative retinopathy was reduced by 78% during the four years. Suboptimal control during adolescence appears to have a lasting harmful effect, even when better glycaemic control is achieved later. Those caring for children and adolescents with type 1 diabetes may worry about the demands on the family and child of achieving good glycaemic control with intensive therapy. However, good glycaemic control is associated with better quality-of-life scores (QOL) in adolescents and less perceived burden by their parents.8 The intensity of the insulin regimen does not adversely affect QOL. Clearly, the demands of achieving good control are less than the consequences of poor control.8 The limiting factor of achieving ideal glycaemic control remains hypoglycaemia, excluding other problems of adherence or family functioning. Adolescents in the DCCT had higher rates of hypoglycaemia than their adult counterparts, despite having higher HbA1c levels.6 Glucagon secretion, which stimulates hepatic glycogenolysis, is blunted early in the course of type 1 diabetes, increasing the patient's vulnerability to hypoglycaemia. Further, the blood glucose threshold level for catecholamine release in response to hypoglycaemia is lowered in patients with better glycaemic control and this counter-regulatory response is most blunted during sleep.9 Recently available continuous blood glucose monitoring devices have shown that nocturnal hypoglycaemia is frequent in children. However, both new insulin analogues and continuous subcutaneous insulin therapy hold promise of improving control without the attendant increased risk of hypoglycaemia. In Western Australia, children with type 1 diabetes had more hypoglycaemia in association with falling HbA1c levels until 1995;4 since then their control has improved further, but without increased hypoglycaemia. Can the DCCT recommendations that adolescents receive intensive therapy be reproduced in routine care? The Hvidore Study Group has followed more than 2500 children and adolescents over three years in Europe, Canada and Japan.5 Despite more use of intensive therapy, glycaemic control did not necessarily improve with wide differences between paediatric centres. Intensive therapy demands intensive follow-up, education and support, as well as resources that many Australian paediatric diabetes units do not have if most patients are to be supported in this way. Most success in implementing the DCCT recommendations is reported from well-resourced units using diabetes clinical nurse consultants. While it is recommended that adolescents with type 1 diabetes receive intensive therapy, schedules need to be individualised. For example, some schoolchildren need insulin at afternoon tea, most adolescents need longer-acting insulin before bed for night control, and many preschoolers are managed on intermediate-acting insulin in the morning with small doses of insulin analogues to cover hyperglycaemia later in the day. Insulin pumps may provide the best solution for some patients, especially those with frequent hypoglycaemia or hypoglycaemic unawareness, but without government subsidy they are not affordable for most families. None of these options are easy for children and their families and, for some, intensive therapy is not possible. Insulin omission and chronic poor glycaemic control remain problems in adolescence and require ongoing intervention.10 The NSW and ACT study has demonstrated a relatively fast decline in HbA1c levels3 since the DCCT findings. However, glycaemic control (and risk of long term vascular complications) is unlikely to improve further in population studies unless multidisciplinary resources increase. It is especially relevant for more educators to be trained in the unique problems of improving control in this age group, and for their expertise to be available to all children.

Jennifer J Couper MB ChB, MD, FRACP

Publicly available reports of "surgical waiting times" are, at face value, of interest to patients and referring doctors wishing to access surgical care. Such information might be expected to provide a reasonable indication of the absolute time to surgical intervention for an individual patient, and allow reasonable conclusions to be drawn on the relative performance (in terms of waiting times) of surgical services. Definition Healthcare performance indicators: statistics or other units of information which reflect, directly or indirectly, the performance of the healthcare system in maintaining or increasing the well-being of its target population. Surgical waiting times are a specific example of "healthcare performance indicators" (see Definition). In addition to providing information for users, such indicators are likely to inform the opinions of politicians, journalists, hospital managers and state and federal health departments on the adequacy of our healthcare system and relative hospital or regional performances. They may be used to construct "league tables" of the relative performance of surgical units — individual hospitals, surgical units or surgeons may be deemed to have "good" or even "substandard" performance. Public outcries and political pointscoring are likely to ensue. Good indicators should be easy to understand and use by the intended audience. Depending on how these data are collected, processed and presented, reported waiting time data might or might not provide useful information to people seeking guidance on time to treatment. Reports of surgical waiting times that use different definitions of "waiting time", or simply report on past performance, are of limited value. Waiting time data presented as the frequency with which a certain proportion of patients receive treatment within a stated time (eg, 75% treated within 4 weeks) may also fail to adequately inform patients or general practitioners as to likely delays. Few existing systems are capable of adjusting for delays before initial surgical consultation (ie, waiting time to get onto the surgical waiting list), let alone factors such as primary illness severity, comorbidity or health insurance status — all of which influence actual waiting times. In this issue of the Journal (page 253), Cromwell et al report an assessment of the utility of information regarding surgical waiting times available on the World Wide Web.1 Their findings indicate that current Web-derived information has significant shortcomings in data quality. They conclude that waiting time data currently published on the Web are, by and large, unsuitable for informing either clinician referral or patient decision-making.1 This critique should not be misinterpreted as an example of the well-recognised "dot.com" data reliability phenomenon. It is not just Web-based sources of such data that are open to criticism. Analysis of healthcare performance indicator data derived from any existing sources would generate similar critiques, with similar caveats required on interpretation and use.2,3 The appropriate desire to develop performance indicators in healthcare has often seen a race to deliver indicators overwhelm the need for methodological rigour in development and implementation. All too often, too little emphasis is placed on initial identification of who will use the indicator and how and why they will apply the data. The absence of such ab initio clarity of purpose leads to performance indicators that do not meet the needs and expectations of consumers, providers or purchasers of healthcare services.2-5 Surgical waiting times, and many other indicators, generate a natural curiosity to compare or rank relative performance. For comparisons to be made, common indicator definitions must exist and be systematically applied in data generation, with common data collection methodologies and results that are risk-adjusted. As Cromwell et al found, requirements for clear, consistent definitions are frequently not met, rendering comparisons invalid.2-8 It is crucial that people intending to use indicator data for judging comparative performance, or in any potentially punitive fashion, fully understand the strengths and weaknesses of the primary data. Perhaps the greatest error by those who use indicator data is that of assuming the indicator is an objective measure of relative performance based solely upon its apparent face validity. Reported surgical waiting times would then be assumed to be a direct linear measure of access to care. This ignores evidence that clinician decision-making processes and administrative practices have major impacts on reported waiting times. Without adjustment for relative urgency or disease severity (at a minimum), reports of waiting times are of limited utility. Significant progress has been made in developing and refining healthcare performance measurement locally (by the Australian Council on Healthcare Standards among others) and internationally (by groups such as the Joint Commission on Accreditation of Healthcare Organisations and the Health Care Financing Administration in North America). There is, however, still considerable scope for improving the methodological rigour of both indicator development and application in the field. At present, the reliability and utility of indicator data cannot be assumed. Most current indicators of healthcare performance should be viewed as tools that prompt additional inquiry, rather than allowing definitive judgements on quality and safety of care. Over time, robust, credible indicators will increasingly become available to reliably inform consumers and allow accountability to purchasers of healthcare services. Nevertheless, given the complexity of healthcare, the predominant enduring benefit from attempts to measure performance in healthcare is likely to be the use of data generated by providers of care to provoke reflection on existing practice and to plan efforts at improving care.

Neil W Boyce FRACP, PhD, MRACMA

Malaria remains a global crisis that kills at least one to two million people per year, mainly children in sub-Saharan Africa.1 Forty per cent of the world's population is at risk of malaria, and each year more than 300 million people have episodes of acute malaria. In recent times, there has been a breakdown in malaria control programs. This has been caused by failure of health systems in the poorest countries, as well as the emergence of mosquitoes resistant to insecticides and malaria parasites resistant to cheap, widely available drugs. In addition, population movements, large-scale development projects, civil wars and conflicts, as well as environmental changes, have all acted in concert to increase the number of individuals at risk of malaria. In Papua New Guinea, for example, malaria is the commonest cause of outpatient presentation and accounts for an estimated 27% of all attendances at health facilities.2 In some Papua New Guinea provinces, malaria is the reason for more than 40% of health centre attendances, and equals pneumonia as a primary cause of death.2 In recognition of the need for a renewed attack on malaria, a global strategy for malaria control was presented to a World Health Organization Conference of Health Ministers in 1992.3 The strategy, now incorporated into the Roll Back Malaria Campaign, promoted a new philosophy emphasising malaria control (in contrast to eradication), and acknowledging the need for different approaches to disease control in different populations. For example, the approach to malaria control in children and pregnant women in Africa is different to that in adult refugee populations. The strategy emphasised the importance of political commitment, such as that given by the heads of State and governments of African countries in Nigeria in 2000 (the Abuja Declaration).4 All participants resolved to commit to an intensive effort to reduce the burden of malaria by strengthening health systems, implementing action plans, improving local capacity, promoting early recognition and treatment of clinical malaria, and reinforcing efficacious preventive measures such as the use of impregnated bednets and chemoprophylaxis. An important component of the strategy is the development of new antimalarial drugs and vaccines. Vaccines have been shown to be one of medicine's most cost-effective interventions. A malaria vaccine that protects for one to five years with 50% efficacy could substantially reduce all-cause child mortality in endemic areas. The cost of such an intervention compares very well with that of using insecticide-treated bednets, and is likely to have major economic as well as social benefits for the populations currently threatened by malaria. An "experiment of nature" suggests that developing a vaccine should be possible. Although many children die of malaria, the majority survive the life-threatening risk of the first few years of exposure and develop clinical immunity. Provided they continue to be exposed to malaria, this immunity protects them from severe disease for the rest of their lives, except during pregnancy. Unfortunately, the immune response that correlates with protection in these lifelong residents of endemic areas has not been identified, so development of a vaccine that mimics this immunity will be difficult. Moreover, malarial parasites demonstrate extreme antigenic diversity. Recent developments, including better methods for antigen production, improved adjuvants and novel delivery systems, provide optimism that sustained and appropriate long-lived immunity can be achieved. Vaccines could be directed against the sporozoite stage of the malaria parasite to prevent infection, or against the stages in human blood — the asexual stage to prevent clinical disease, or the sexual stage to prevent transmission. The malaria vaccine which has been studied in most detail is designed to induce immunity to the sporozoite and the infected liver cell (ie, to stop sporozoites invading liver cells and to kill sporozoite-infected liver cells). In early studies it was shown to induce protective immunity against experimental challenge.5 Under conditions of natural exposure (in semi-immune adult men in The Gambia),6 the vaccine was shown to be safe and well tolerated, with an estimated efficacy (decrease in malaria infection) of 70% in the first nine weeks of follow-up. However, over the 15 weeks of observation, the efficacy fell to 34%. Further trials will determine whether improved efficacy can be achieved in young children. Australian research efforts have led to a multicomponent recombinant protein vaccine targeting the asexual blood stages. This vaccine was tested recently by the Papua New Guinea Institute of Medical Research and its collaborators. The vaccine caused a 62% reduction in parasite density in children, without any harmful side effects.7 Further development will be necessary to produce a vaccine sufficiently efficacious for routine use. In the past there has been a serious lack of funding for research into malaria, partly because companies engaging in this type of research did not expect it to be profitable. A major change has occurred of late, with increased funding from the Wellcome Trust in the United Kingdom, and from the United States through the National Institutes of Health. A grant from the Bill and Melinda Gates Foundation has funded the Malaria Vaccine Initiative of the Program for Appropriate Technology in Health (PATH) (http://www.malariavaccine.org). This worldwide initiative has the specific goal of enhancing the transition of the many promising candidate vaccines from the laboratory to "proof of principle" research in phase I clinical trials. It has funded Australian projects developing vaccines from asexual stage (merozoite) antigens by researchers at Monash University, La Trobe University and the Queensland Institute for Medical Research, partnered by Biotech Australia (New South Wales), the Cooperative Research Centre for Vaccine Technology (Queensland) and Progen Industries Limited (Queensland).8 There are still many challenges in developing a malaria vaccine, such as the need to cope with diverse antigenic types and the importance of stimulating a lifelong response that is boosted by natural infection. Vaccine-induced sterilising immunity that is not boosted by exposure to malaria could put an individual at increased risk when the vaccine-induced immunity wanes. Most importantly, we need vaccines that can be incorporated into national immunisation programs as part of a coordinated, holistic approach to malaria control. Research to find new methods for vector control and new drugs must also continue, as we know from past antimalarial campaigns that a single technology will not be sufficient to control this devastating disease.

Graham V Brown PhD, FRACP · John C Reeder PhD

Hollywood celebrity Pamela Anderson's announcement that she has hepatitis C was a major talking point at this recent conference. Unlike similar announcements of HIV infection, Ms Anderson has not positioned herself as a celebrity campaigner — there is no princess or pop star championing the rights of people with hepatitis C or demanding extra funding for research or services. Hepatitis C has been characterised as an "epidemic of difference",1 affecting people from a wide variety of ethnic, cultural and class backgrounds, with implications for the ability of people with hepatitis C to organise and advocate for changes in policy to improve their lives. Until recently, a study by Crofts et al (1997) was the only example of academic research to focus on hepatitis C-related discrimination and to highlight the part played by healthcare professionals.2 It is timely that many presentations from the recent Third Australasian Conference on Hepatitis C, held in Melbourne in March 2002, highlighted the discriminatory attitudes and practices of some healthcare workers when treating and working among people with hepatitis C. Presentations discussed both institutional and interpersonal discrimination against people with hepatitis C. The relatively low level of community and government concern regarding this epidemic was alluded to in several presentations, suggesting a form of systemic discrimination. There have been more than 160 000 notified cases of hepatitis C since antibody testing became available in 1990.3 Alex Wodak (Director, Alcohol and Drug Service, St Vincent's Hospital, Sydney) described the estimated incidence of 16 000 new infections in 2001 as one every 33 minutes.4 Given the high prevalence and estimated incidence of the hepatitis C epidemic, Nick Crofts (Head, Epidemiology and Social Research Unit, Macfarlane Burnet Institute for Medical Research and Public Health [Burnet Institute], Melbourne) questioned whether the government response might have been quicker and better funded if hepatitis C primarily affected people other than injecting drug users.5 Similarly, conference presentations from people with hepatitis C, community organisations and researchers challenged the positioning of hepatitis C (in their view) as a "second-class" disease. These presentations indicated that people with hepatitis C are tainted as past or current drug users and suffer attitudes of blame from healthcare professionals, often described as "userphobia". Grant McNally (Chair, United Kingdom Assembly on Hepatitis C) summarised the effects of these negative attitudes on people with hepatitis C: they take for granted and come to expect substandard levels of healthcare.6 Academic presentations documented the effects of discrimination on prevention, testing, living with hepatitis C, quality of life, treatment and prognosis. A paper by Michael Kerger (Manager, Centre for Harm Reduction, Burnet Institute), Campbell Aitken (Research Fellow, Centre for Harm Reduction, Burnet Institute) and Nick Crofts discussed piloting peer-delivered hepatitis C testing and counselling at a needle and syringe program.7 The authors highlighted current injecting drug users' fear of discrimination following disclosure of their injecting status to doctors. This fear meant that users often did not present for hepatitis C testing. Max Hopwood (Senior Research Officer, National Centre in HIV Social Research, University of New South Wales, Sydney) and Erica Southgate (Research Fellow, National Centre in HIV Social Research) reported that people with hepatitis C at times feel pressured by healthcare workers to reveal their hepatitis C status.8 They described how some people with hepatitis C were refused medical treatment and had their positive serostatus disclosed to other healthcare workers without permission. Similarly, in discussing women's experiences of living with hepatitis C while using drugs, Mary O'Brien (Researcher, Australian Centre for Research into Sex, Health and Society, La Trobe University, Melbourne)9 reported that participants in their study who were current injecting drug users were treated less favourably by healthcare professionals than women with hepatitis C who were not currently injecting drugs. Sandy Gifford (Professor, School of Health Sciences, Deakin University, Melbourne) presented a paper noting the harmful impact of hepatitis C-related discrimination on participants' quality-of-life measures, including physical and emotional health scores.10 The participation of people from the affected communities provided opportunity for elaboration and reflection on research from the perspective of those primarily affected by hepatitis C. People with hepatitis C spoke informally of feelings of guilt, shame, low self-esteem and self-worth that arose as a result of their interactions with some healthcare professionals. They claimed that internalising stigma led to missed opportunities for care and support from social networks and had implications for people's access to healthcare services. Deb Warneke (Metropolitan Educator, Hepatitis C Council of South Australia) and Richard Hanssens (Representative, Hepatitis C Resource Centre, Christchurch, New Zealand) provided personal views and case studies of the effect of hepatitis C in other domains of life experience —within family circles and the workplace.11,12 These conference papers support the report of the New South Wales Anti-Discrimination Board Enquiry, which found that hepatitis C is a highly stigmatised condition and discrimination is rife, especially in healthcare settings.13 The report states that discrimination results either from an inadequate knowledge of the virus and how it is transmitted, or from a confounding of injecting drug use with hepatitis C virus infection. Both the conference presentations and the Enquiry report acknowledge that not all healthcare workers discriminate against people with hepatitis C. However, it is time for healthcare professionals to acknowledge and address hepatitis C-related discrimination. No short term practical solutions to healthcare workers' discrimination against hepatitis C-positive injecting drug users were proffered. A paper by Piergiorgio Moro (Education and Community Development Officer, Hepatitis C Council of Victoria) suggested that a long term solution would involve organisation and lobbying by the hepatitis C-positive and injecting drug use communities to effect legislative change.14 As implied in many of the conference papers, marginalising people with hepatitis C will impede measures to prevent the further spread of the virus throughout the community, and will contribute much to the burden borne by people with hepatitis C.

Carla J Treloar BSc(Hons), PhD · Max N Hopwood BA(Hons) · Stuart K Loveday BCom

Objectives: To audit glycaemic control and incidence of severe hypoglycaemia in children and adolescents with type 1 diabetes in New South Wales (NSW) and the Australian Capital Territory (ACT).Design: A multicentre, population-based, cross-sectional study from 1 September to 31 December, 1999.Participants: 1190 children and adolescents aged 1.2–15.8 years with type 1 diabetes, identified from three hospital-based paediatric diabetes units, four private city-based paediatric practices and 18 regional outreach clinics in NSW and the ACT.Main outcome measures: HbA1c level and incidence of severe hypoglycaemia (defined by unconsciousness or seizures).Results: The response rate was 67% (1190 of a target group of 1765). The median HbA1c level was 8.2% (interquartile range, 7.6%–9.1%). Significant predictors of HbA1c level in a multiple regression model were duration (b = 0.05; 95% CI, 0.02–0.07) and insulin dose/kg (b = 0.46; 95% CI, 0.27–0.66). At least one episode of severe hypoglycaemia in the previous three months was reported in 6.7%, and the rate of severe hypoglycaemia was 36/100 patient-years. Significant predictors of hypoglycaemia in a Poisson regression model were younger age (P = 0.03), male sex (P = 0.04), longer diabetes duration (P = 0.02), and > 3 daily insulin injections (P = 0.02), but not HbA1c level. Children with diabetes had higher BMI standard deviation scores compared with population standards, and those in the highest quartile of BMI standard deviation score were younger, had shorter diabetes duration and had higher HbA1c level.Conclusions: Many children and adolescents with type 1 diabetes have suboptimal glycaemic control, placing them at high risk of developing microvascular complications. Those with longer diabetes duration are at increased risk of suboptimal glycaemic control and severe hypoglycaemia and should be targeted for interventional strategies.

for the NSW/ACT HbA1c Study Group

Objective: To determine factors associated with hepatic fibrosis development in people with chronic hepatitis C virus (HCV) infection.Methods: As a requirement for access to interferon therapy through the S100 scheme in Australia, individual pretreatment demographic and clinical information was collected on 2986 patients from 61 hospital-based liver clinics from 1 October 1994 through 31 December 1996. Patients with both a hepatic fibrosis score and an estimated duration of HCV infection (910) were divided into 540 with no or minimal hepatic fibrosis (stage 0–1) and 370 with moderate to severe hepatic fibrosis (stage 2–3). Seven factors were examined: age at HCV infection, sex, ethnicity, source of infection, duration of infection, alcohol intake, and mean ALT level. A further analysis was performed for all 1135 patients with a hepatic fibrosis score disregarding age at and duration of HCV infection.Results: In multivariate analysis, four factors were significantly associated with moderate to severe hepatic fibrosis: age at infection (OR, 2.33 for age 31–40 years, 5.27 for age > 40 years, and 0.20 for age < 15 years, compared with 15–20 years); duration of infection (OR, 1.44 for 11–20 years, 2.74 for 21–30 years, and 8.71 for > 30 years, compared with < 11 years); alcohol intake in previous six months (OR, 1.51 for any intake, compared with none); and mean ALT level (OR, 1.81 for 2–3 times, 2.27 for > 3 times, compared with 1.5–2 times the upper limit of normal). In the analysis disregarding age at HCV infection and duration of HCV infection, older age was strongly associated with moderate to severe hepatic fibrosis (OR, 2.32 for age 36–40 years, 2.46 for age 41–50 years, 7.87 for age 51–60 years, and 7.15 for age > 60 years, compared with 16–30 years). There was no association in either analysis with sex or source of HCV infection.Conclusion: These factors may assist in targeting patients for both liver biopsy-based investigation and therapeutic intervention.

Mark Danta MB BS, MPH · Gregory J Dore BSc, FRACP, MPH, PhD · Yueming Li BSc, MAppStat · John M Kaldor PhD · Chris R Vickers BSc, FRACP · Lisa Hennessy · Robert G Batey MSc(Med), MD, FRACP, FRCP · Hugh Harley FRACP · Meng Ngu MB BS, PhD, FRACP · William Reed FRACP, FRCP · Paul V Desmond FRACP · William Sievert MD, FRACP · Geoff C Farrell MD, FRACP

Objective: To examine changes in presentation of primary hyperparathyroidism and rates of parathyroidectomy in Northern Sydney (the Northern Sydney Area Heath Service) and New South Wales (NSW).Design: Retrospective case series January 1962 – December 2001 and audit of the NSW Department of Health inpatient database (1993–1999).Setting: University of Sydney Endocrine Surgical Unit, Royal North Shore Hospital.Participants: 1613 patients undergoing parathyroidectomy during the study period.Main outcome measures: Age-standardised parathyroidectomy rates and indications for surgical intervention.Results: The age-standardised rates of parathyroidectomy for primary hyperparathyroidism in women have increased significantly in Northern Sydney from 0.14 cases per 100 000 in 1976 to 7.7 cases per 100 000 in 1996 (P < 0.001). In NSW there has been an increase in parathyroidectomy rates in women from 5.1 cases per 100 000 in 1993 to 12.3 cases per 100 000 in 1998 (P < 0.001). Osteoporosis was the most common overall indication for surgery in Northern Sydney, accounting for 27% of all cases. The proportion of cases presenting with osteoporosis increased significantly from 4% in 1962–1980 to 34% over the past decade (P < 0.001).Conclusions: The rate of parathyroidectomy procedures has increased markedly in Northern Sydney and in NSW. The investigation of osteoporosis has led to the diagnosis of primary hyperparathyroidism in an increasing proportion of cases and has contributed to the growing surgical referral rates.

Tom S Reeve MD, FRACS · Bruce H Barraclough MB BS, FRACS · Leigh W Delbridge MD, FRACS · Bruce G Robinson MD, FRACP · Phillip Clifton-Bligh MB BS, FRACP · Mark S Sywak MB BS, FRACS · Gordon H Fick PhD

Objective: To compare the quality of care provided by general practitioners participating in diabetes shared-care registers with that provided by GPs not using registers.Design: Cross-sectional comparison using Health Insurance Commission (HIC) data for patients attending the GPs.Participants and setting: 155 GPs using diabetes registers, 459 GPs not using registers, and their patients with diabetes (as identified by HIC criteria). The study analysed data for the period January 1996 to December 1998 and was based on Divisions of General Practice within the South Western Sydney Area Health Service.Main outcome measures: Frequency of visits to GPs and tests ordered within each of six six-month periods.Results: GPs using the registers had more patients with diabetes, and saw those patients more frequently, than GPs not using registers. "Register" GPs also ordered tests (for HbA1c and microalbuminuria) more frequently than "non-register" GPs.Conclusion: GPs who participated in diabetes registers were more likely to provide patient care that more closely adhered to evidence-based guidelines than those who did not. Further research is needed to determine whether this was the result of characteristics of the GPs themselves, or their practices, or a was a consequence of their participation.

Mark F Harris DRACOG, FRACGP, MD · Fernando A Infante MB BS · Brian I O'Toole PhD, MPH · Debbie Priddin RN, BSocSci · Warwick Ruscoe MB BS, FRACMA

Objectives: To assess Web-based waiting time information services to identify how they aimed to meet the information needs of patients and general practitioners, and to evaluate how well waiting time information was presented.Design: A cross-sectional survey of six government websites in English-speaking countries with publicly funded hospitals. Sites were evaluated on the clarity of instructions about how their information should be used, and the accuracy of the statistics they contained was assessed indirectly using methodological criteria.Results: The services were judged to encourage GPs and patients to use the statistics to avoid surgical units with long waiting times, but overall advice was poor. Services did not state whether the statistics predicted expected waiting times, and just one stated that the statistics were only intended as a guide. Statistics were based on different types of data, and derived at different levels of aggregation, raising questions of accuracy. Most sites explained waiting list terms, but provided inadequate advice on the uncertainty associated with making statistical inferences.Conclusions: GPs and patients should use Web-based waiting time information services cautiously because of a lack of guidance on how to appropriately interpret the presented information.

David A Cromwell BSc, MSc · David A Griffiths BSc, PhD · Irene A Kreis MD, PhD

Sample size must be planned carefully to ensure that the research time, patient effort and support costs invested in any clinical trial are not wasted. Item 7 of the CONSORT statement relates to the sample size and stopping rules of studies (see Box 1); it states that the choice of sample size needs to be justified.1 Ideally, clinical trials should be large enough to detect reliably the smallest possible differences in the primary outcome with treatment that are considered clinically worthwhile. It is not uncommon for studies to be underpowered, failing to detect even large treatment effects because of inadequate sample size.2 Also, it may be considered unethical to recruit patients into a study that does not have a large enough sample size for the trial to deliver meaningful information on the tested intervention. Components of sample size calculationThe minimum information needed to calculate sample size for a randomised controlled trial in which a specific event is being counted includes the power, the level of significance, the underlying event rate in the population under investigation and the size of the treatment effect sought. The calculated sample size should then be adjusted for other factors, including expected compliance rates and, less commonly, an unequal allocation ratio. Power: The power of a study is its ability to detect a true difference in outcome between the standard or control arm and the intervention arm. This is usually chosen to be 80%. By definition, a study power set at 80% accepts a likelihood of one in five (that is, 20%) of missing such a real difference. Thus, the power for large trials is occasionally set at 90% to reduce to 10% the possibility of a so-called "false-negative" result. Level of significance: The chosen level of significance sets the likelihood of detecting a treatment effect when no effect exists (leading to a so-called "false-positive" result) and defines the threshold "P value". Results with a P value above the threshold lead to the conclusion that an observed difference may be due to chance alone, while those with a P value below the threshold lead to rejecting chance and concluding that the intervention has a real effect. The level of significance is most commonly set at 5% (that is, P = 0.05) or 1% (P = 0.01). This means the investigator is prepared to accept a 5% (or 1%) chance of erroneously reporting a significant effect. Underlying population event rate: Unlike the statistical power and level of significance, which are generally chosen by convention, the underlying expected event rate (in the standard or control group) must be established by other means, usually from previous studies, including observational cohorts. These often provide the best information available, but may overestimate event rates, as they can be from a different time or place, and thus subject to changing and differing background practices. Additionally, trial participants are often "healthy volunteers", or at least people with stable conditions without other comorbidities, which may further erode the study event rate compared with observed rates in the population. Great care is required in specifying the event rate and, even then, during ongoing trials it is wise to have allowed for sample size adjustment, which may become necessary if the overall event rate proves to be unexpectedly low. Size of treatment effect: The effect of treatment in a trial can be expressed as an absolute difference. That is, the difference between the rate of the event in the control group and the rate in the intervention group, or as a relative reduction, that is, the proportional change in the event rate with treatment. If the rate in the control group is 6.3% and the rate in the intervention arm is 4.2%, the absolute difference is 2.1%; the relative reduction with intervention is 2.1%/6.3%, or 33%. Estimating the plausible effect of treatment to be sought in a randomised controlled trial provides a further challenge, and may be the most common problem for reported trials. Too frequently, studies are designed to identify an implausibly large treatment effect (for example, a 30% to 50% reduction), when most important treatments that have been adopted into clinical practice have shown more modest benefits. When studies are designed to find unrealistically large reductions and fail, smaller real reductions are inevitably rendered statistically non-significant, leading to confusion about the value of the intervention studied. To resolve uncertainty, the study then needs to be repeated elsewhere, but with a larger sample size than before. Wherever possible, the minimum worthwhile difference in response should be determined from phase II or pilot studies and expert opinion from colleagues. Investigators should take into consideration any cost or logistical advantages or disadvantages of the interventional treatment compared with standard care. From these components, sample size can be calculated as shown in Box 2. It can be seen that the required sample size increases as the chosen significance level becomes smaller and as the chosen power increases. Also, even a small change in the expected absolute difference with treatment has a major effect on the estimated sample size, as the sample size is inversely proportional to the square of the difference. Thus, if 1000 participants per treatment group are required to detect an absolute difference of 4.8%, 4000 per treatment group would be required to detect a 2.4% difference. Precise calculation of sample size for different types of outcomes (continuous, binary and time-to-event) is discussed in standard texts.3-5 A checklist for determining sample size is given in Box 3. Effect of complianceA major limitation of many sample size calculations is the failure to account for patients' predictable lack of compliance with their allocated treatments. As compliance losses directly affect the size of the achievable treatment difference, they also affect the estimated sample size in a non-linear fashion. For example, a placebo-controlled study needing 100 patients per treatment arm, with 100% compliance, would require about 280 patients per arm if compliance is only 80% in each group (that is, 20% of patients allocated the investigational treatment fail to take it, and 20% of patients allocated to the placebo-control arm cross over to the investigational treatment). The compliance adjustment formula is adjusted n per arm equals N/([c1+c2–1]2), where c1 and c2 are the average compliance rates per arm (so, in the above example, adjusted n = 100/([0.8+0.8–1]2) = 280). Allocation ratioA one-to-one allocation to intervention and control treatment arms is the most common form of random allocation and results in the smallest sample size requirement. Sometimes different allocation ratios are chosen, resulting in a larger total sample size needed to achieve the same power. This may be justified where the investigational treatment is unusually expensive or complicated to administer. Reporting the sample size section of the protocolThe sample size calculation should be described in sufficient detail to allow its use in other protocols. The power, level of significance and the control and intervention event rates should be clearly documented. Information on the scheduled duration of the study, any adjustment for non-compliance and any other issues that formed the basis of the sample size calculation should be included. For continuous outcomes, in particular (eg, blood pressure), assumptions made about the distribution or variability of the outcome should be explicitly stated. ConclusionEstimating sample size is important in the design of clinical trials, and the quality of the estimate ultimately depends on the quality of the information used to derive it. Care should be taken to avoid overestimating the likely event rate and the feasible effects of treatment. The objectives and outcome measures of the study must be clearly stated,6 and the information used in calculating the sample size should reflect as closely as possible the type of data that will be gathered from the trial in question. Professional advice should be sought before embarking on any major trial project. 1: CONSORT checklist of items to include when reporting a trial1 Selection and topic Item no. Description Methods Sample size 7 How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules 2: Generic expression for calculating sample size Sample size α (power, inverse function of significance level*) (absolute difference)2 * As the P value becomes smaller, the function of the significance level increases. 3: Checklist for determining sample size for clinical trials Estimate the event rate in the control group by extrapolating from a population similar to the population expected in the trial. Determine, for the primary outcome, the smallest difference that will be of clinical importance. Determine the clinically justifiable power for the particular trial. Determine the significance level or probability of a "false positive" result that is scientifically acceptable. Adjust the calculated sample size for the expected level of non-compliance with treatment.

Adrienne Kirby MSc · Val Gebski MStat · Anthony C Keech FRACP, MScEpi

Trial: Hobbs M, Mayou R, Harrison B, Worlock P. A randomised controlled trial of psychological debriefing for victims of road traffic accidents. BMJ 1996; 313: 1438–1439. Mayou R, Ehlers A, Hobbs M. Psychological debriefing for victims of road traffic: three year follow-up of a randomised controlled trial. Br J Psychiatry 2000; 176: 589–593. QuestionHow effective is psychological debriefing for people subject to unpleasant psychological shock? Trial details Design: Randomised controlled trial of psychological debriefing. Setting: A British teaching hospital (the Radcliffe Hospital, Oxford). Patients: 66 men and 40 women, aged 17–69 years, admitted to hospital after a motor vehicle accident. Most had been the driver of a car. Median admission duration was four days for the 52 control patients and eight days for the 54 who underwent the intervention. Interventions: A debriefing of about one hour on Day 2 of admission, encouraging patients to describe the accident and express their emotions, followed by a cognitive appraisal which included describing common reactions to traumatic experiences and suggesting a range of people who might be able to assist in the future, including the patient's general practitioner. 91 patients were assessed at four months and 61 were assessed at three years. Control patients had no debriefing or counselling. Main outcome measures: Impact of Event Scale (IES, which focuses on intrusive thoughts and avoidance of similar situations to the event); Brief Symptom Inventory (BSI, a measure of 53 symptoms); and other questions related to physical pain and functional activities. Main results: At four months there was still considerable psychological morbidity among the patients who were followed up. There was a significant difference (P < 0.05) in changes of IES between the 42 who received the intervention, in whom it increased from 15 (standard deviation [SD], 15) to 16 (SD, 15), and the 49 controls, in whom it fell from 15 (SD, 12) to 13 (SD, 14). Similarly, two subscales of the BSI score changed significantly between the intervention group, among whom it deteriorated from 0.5 (SD, 0.5) to 0.6 (SD, 0.8), and the control s, in whom it hardly changed from 0.4 (SD, 0.3) to 0.4 (SD, 0.4). Among the 61 patients followed for three years, the 30 randomised to receive the intervention were significantly worse, by self-report, both psychologically and physically. Their mean IES score deteriorated from a baseline of 15 (SD, 14) to 16 (SD, 18). In comparison, scores for the 31 control patients improved from 16 (SD, 12) to 13 (SD, 17). The difference in change was significant (P < 0.05). Among all patients with high initial scores, these decreased among the controls but not among those receiving the intervention. Conclusion: Psychological counselling should only be used in the context of trials rather than routine care. CommentaryRationale for the trialVictims of psychological shock are vulnerable for many years after the incident to a cluster of symptoms (including intrusive thoughts, avoidance symptoms, functional problems extending to social problems, and pain and other physical symptoms), commonly called "post-traumatic stress" disorder. The response of society has been to try to deflect this.1 For example, after the Port Arthur tragedy, teams of counsellors were flown to the scene and made available for those who wanted to talk through the horrors of the incident. The trial under consideration was a clever way of testing such debriefing for people subject to a sudden, unexpected event in which some were physically hurt. Trial methodsThe methods appear to have been well constructed. However, despite random allocation by random number tables, the patients in the intervention group were worse affected (nearly double the hospital stay and higher IES scores). Presumably, this happened by chance, but it might explain some of the result. Also, the rate of follow-up at four months was higher among control patients (49 out of 52) than intervention patients (42 of 54), although both follow-up rates were equally poor at three years. It is reassuring that the different measures of severity were the same for those followed up and those not. New informationThe results are compelling. There was a very strong suggestion that the sort of counselling we expect should be effective was actually harmful. It might be that we have some sort of mechanism ("denial", or a method of dismissing disturbing memories from our minds) that protects us from further psychological effects that interfere with normal living. Moreover, this finding is supported by evidence from another trial in which women who had had operative childbirth were debriefed to defer postnatal depression. This intervention also failed to be effective, with a trend in the direction of causing more harm than good.2 Implications for clinical practiceThis trial's findings challenge an assumed and conventional approach to protecting people against post-traumatic stress disorder. It may be another case of the empirical informing the psychopathological process. We should reconsider the impulse to assist people who have undergone an unpleasant psychological event by counselling them and getting them to talk about it and relive the event. It may be harmful. Could it be that the unfashionable British "stiff upper lip" is the better approach after all? We should provide such psychological counselling only in the context of trials rather than routine care. The stroke of genius here was that the authors thought to challenge an intervention whose benefits seemed self-evident. From this we learn that we must continue to do so with many other interventions whose benefits we take for granted.

Christopher B Del Mar MD, FRACGP, FAFPHM

In Australia, the lifetime use of cocaine is rising, with 3% of the population aged over 14 using cocaine in 1991, increasing to 4.5% in 1998, and cocaine use accounting for 10% of all deaths secondary to illicit drug use in 1998. Cocaine is prepared from the leaves of the plant Erythroxylon coca, and is available as cocaine hydrochloride (a water-soluble powder or granule which can be taken orally, intravenously or intranasally) and as "freebase" or "crack" cocaine (heat stable, melting at high temperatures, thus allowing it to be smoked). Acute myocardial infarction (AMI) is the most commonly reported cardiac consequence of cocaine misuse, usually occurring in men who are young, fit and healthy and who have minimal, if any, risk factors for cardiovascular disease. The mechanism by which cocaine induces AMI is largely not understood. Cocaine effect should be seriously considered in any young patient with minimal risk factors for cardiac disease presenting with AMI, dilated cardiomyopathy, myocarditis or cardiac arrhythmias.

Gabriella Vasica MB BS(Hons), BSc(Hons) · Christopher C Tennant MPH, MRCPsych, FRANZCP

To our readers: For most of us, the word "professional" conjures up an image of an individual with expertise in a discrete area of knowledge and a commitment to use this expertise judiciously. The word "doctor" has similar connotations, but also suggests the altruism of service to patients and society. Of late, however, medical professionalism has been buffeted by the tumultuous changes affecting the industrialised world. These include the explosion of information technology, the increasing dominance of corporatism and of government management of social services, and the ascendancy of individualism. These changes, and their attendant uncertainty, have been accompanied by a questioning of the purpose and values of the medical profession. At the same time, these very stressors have also awakened an interest in medical professionalism, particularly in North America and the United Kingdom. This interest has yet to reach Australia. In view of this, the Medical Journal of Australia is pleased to introduce the Charter on Medical Professionalism to its readers. The charter first appeared in the Annals of Internal Medicine and the Lancet earlier this year, and is the outcome of the Medical Professionalism Project, which involved the American Board of Internal Medicine, the American College of Physicians–American Society of Internal Medicine and the European Federation of Internal Medicine. The charter should be read by all in our profession, and individual doctors will have to decide whether they will subscribe and adhere to its precepts. These include the principles of social justice, improving the quality of care and sustaining and strengthening the research base of medicine. The Charter on Medical Professionalism should not only be advocated by our medical schools, learned colleges or politico-professional bodies, but by all in our profession As noted by Harold Sox, editor of the Annals of Internal Medicine, in his prologue to the charter, ". . . the challenge will be to live by the precepts and to resist efforts to impose corporate (or government [my words]) mentality on a profession of service to others . . . The responsibility for acting on these principles and commitments lies squarely on our shoulders." Martin B Van Der Weyden Editor Medical Journal of Australia Physicians today are experiencing frustration as changes in the healthcare delivery systems in virtually all industrialised countries threaten the very nature and values of medical professionalism. Meetings among the European Federation of Internal Medicine, the American College of Physicians and American Society of Internal Medicine (ACP-ASIM), and the American Board of Internal Medicine (ABIM) have confirmed that physicians' views on professionalism are similar in quite diverse systems of healthcare delivery. We share the view that medicine's commitment to the patient is being challenged by external forces of change within our societies. Recently, voices from many countries have begun calling for a renewed sense of professionalism, one that is activist in reforming healthcare systems. Responding to this challenge, the European Federation of Internal Medicine, the ACP-ASIM Foundation, and the ABIM Foundation combined efforts to launch the Medical Professionalism Project (<www.professionalism.org>) in late 1999. These three organisations designated members to develop a "charter" to encompass a set of principles to which all medical professionals can and should aspire. The charter supports physicians' efforts to ensure that the healthcare systems and the physicians working within them remain committed both to patients' welfare and to the basic tenets of social justice. Moreover, the charter is intended to be applicable to different cultures and political systems. PreambleProfessionalism is the basis of medicine's contract with society. It demands placing the interests of patients above those of the physician, setting and maintaining standards of competence and integrity, and providing expert advice to society on matters of health. The principles and responsibilities of medical professionalism must be clearly understood by both the profession and society. Essential to this contract is public trust in physicians, which depends on the integrity of both individual physicians and the whole profession. At present, the medical profession is confronted by an explosion of technology, changing market forces, problems in healthcare delivery, bioterrorism, and globalisation. As a result, physicians find it increasingly difficult to meet their responsibilities to patients and society. In these circumstances, reaffirming the fundamental and universal principles and values of medical professionalism, which remain ideals to be pursued by all physicians, becomes all the more important. The medical profession everywhere is embedded in diverse cultures and national traditions, but its members share the role of healer, which has roots extending back to Hippocrates. Indeed, the medical profession must contend with complicated political, legal, and market forces. Moreover, there are wide variations in medical delivery and practice through which any general principles may be expressed in both complex and subtle ways. Despite these differences, common themes emerge and form the basis of this charter in the form of three fundamental principles and as a set of definitive professional responsibilities. Fundamental principlesPrinciple of primacy of patients' welfareThis principle is based on a dedication to serving the interest of the patient. Altruism contributes to the trust that is central to the physician–patient relationship. Market forces, societal pressures, and administrative exigencies must not compromise this principle. Principle of patients' autonomyPhysicians must have respect for patients' autonomy. Physicians must be honest with their patients and empower them to make informed decisions about their treatment. Patients' decisions about their care must be paramount, as long as those decisions are in keeping with ethical practice and do not lead to demands for inappropriate care. Principle of social justiceThe medical profession must promote justice in the healthcare system, including the fair distribution of healthcare resources. Physicians should work actively to eliminate discrimination in healthcare, whether based on race, gender, socioeconomic status, ethnicity, religion, or any other social category. A set of professional responsibilitiesCommitment to professional competencePhysicians must be committed to lifelong learning and be responsible for maintaining the medical knowledge and clinical and team skills necessary for the provision of quality care. More broadly, the profession as a whole must strive to see that all of its members are competent and must ensure that appropriate mechanisms are available for physicians to accomplish this goal. Commitment to honesty with patientsPhysicians must ensure that patients are completely and honestly informed before the patient has consented to treatment and after treatment has occurred. This expectation does not mean that patients should be involved in every minute decision about medical care; rather, they must be empowered to decide on the course of therapy. Physicians should also acknowledge that, in healthcare, medical errors that injure patients do sometimes occur. Whenever patients are injured as a consequence of medical care, patients should be informed promptly because failure to do so seriously compromises patients' and societal trust. Reporting and analysing medical mistakes provides the basis for appropriate prevention and improvement strategies and for appropriate compensation to injured parties. Commitment to patients' confidentialityEarning the trust and confidence of patients requires that appropriate confidentiality safeguards be applied to disclosure of patients' information. This commitment extends to discussions with people acting on a patient's behalf when obtaining the patient's own consent is not feasible. Fulfilling the commitment to confidentiality is more pressing now than ever before, given the widespread use of electronic information systems for compiling data on patients and an increasing availability of genetic information. Physicians recognise, however, that their commitment to confidentiality must occasionally yield to over-riding considerations in the public interest (for example, when patients endanger others). Commitment to maintaining appropriate relationships with patientsGiven the inherent vulnerability and dependency of patients, certain relationships between physicians and patients must be avoided. In particular, physicians should never exploit patients for any sexual advantage, personal financial gain, or other private purpose. Commitment to improving quality of carePhysicians must be dedicated to continuous improvement in the quality of healthcare. This commitment entails not only maintaining clinical competence but also working collaboratively with other professionals to reduce medical error, increase patients' safety, minimise overuse of healthcare resources, and optimise the outcomes of care. Physicians must actively participate in the development of better measures of quality of care and the application of quality measures to assess routinely the performance of all individuals, institutions, and systems responsible for healthcare delivery. Physicians, both individually and through their professional associations, must take responsibility for assisting in the creation and implementation of mechanisms designed to encourage continuous improvement in the quality of care. Commitment to improving access to careMedical professionalism demands that the objective of all healthcare systems be the availability of a uniform and adequate standard of care. Physicians must individually and collectively strive to reduce barriers to equitable healthcare. Within each system, the physician should work to eliminate barriers to access based on education, laws, finances, geography, and social discrimination. A commitment to equity entails the promotion of public health and preventive medicine, as well as public advocacy on the part of each physician, without concern for the self-interest of the physician or the profession. Commitment to a just distribution of finite resourcesWhile meeting the needs of individual patients, physicians are required to provide healthcare that is based on the wise and cost-effective management of limited clinical resources. They should be committed to working with other physicians, hospitals, and payers to develop guidelines for cost-effective care. The physician's professional responsibility for appropriate allocation of resources requires scrupulous avoidance of superfluous tests and procedures. The provision of unnecessary services not only exposes patients to avoidable harm and expense but also diminishes the resources available for others. Commitment to scientific knowledgeMuch of medicine's contract with society is based on the integrity and appropriate use of scientific knowledge and technology. Physicians have a duty to uphold scientific standards, to promote research, and to create new knowledge and ensure its appropriate use. The profession is responsible for the integrity of this knowledge, which is based on scientific evidence and physicians' experience. Commitment to maintaining trust by managing conflicts of interestMedical professionals and their organisations have many opportunities to compromise their professional responsibilities by pursuing private gain or personal advantage. Such compromises are especially threatening in the pursuit of personal or organisational interactions with for-profit industries, including medical equipment manufacturers, insurance companies, and pharmaceutical firms. Physicians have an obligation to recognise, disclose to the general public, and deal with conflicts of interest that arise in the course of their professional duties and activities. Relationships between industry and opinion leaders should be disclosed, especially when the latter determine the criteria for conducting and reporting clinical trials, writing editorials or therapeutic guidelines, or serving as editors of scientific journals. Commitment to professional responsibilitiesAs members of a profession, physicians are expected to work collaboratively to maximise patients' care, be respectful of one another, and participate in the processes of self-regulation, including remediation and discipline of members who have failed to meet professional standards. The profession should also define and organise the educational and standard-setting process for current and future members. Physicians have both individual and collective obligations to participate in these processes. These obligations include engaging in internal assessment and accepting external scrutiny of all aspects of their professional performance. SummaryThe practice of medicine in the modern era is beset with unprecedented challenges in virtually all cultures and societies. These challenges centre on increasing disparities among the legitimate needs of patients, the available resources to meet those needs, the increasing dependence on market forces to transform healthcare systems, and the temptation for physicians to forsake their traditional commitment to the primacy of patients' interests. To maintain the fidelity of medicine's social contract during this turbulent time, we believe that physicians must reaffirm their active dedication to the principles of professionalism, which entails not only their personal commitment to the welfare of their patients but also collective efforts to improve the healthcare system for the welfare of society. This Charter on Medical Professionalism is intended to encourage such dedication and to promote an action agenda for the profession of medicine that is universal in scope and purpose. Members of the Medical Professionalism Project ABIM Foundation Troy Brennan (Project Chair), Brigham and Women's Hospital, Boston, MA, USA; Linda Blank (Project Staff), ABIM Foundation, Philadelphia, PA, USA; Jordan Cohen, Association of American Medical Colleges, Washington, DC, USA; Harry Kimball, American Board of Internal Medicine, Philadelphia, PA, USA; and Neil Smelser, University of California, Berkeley, CA, USA. ACP-ASIM Foundation Robert Copeland, Southern Cardiopulmonary Associates, LaGrange, GA, USA; Risa Lavizzo-Mourey, Robert Wood Johnson Foundation, Princeton, NJ, USA; and Walter McDonald, American College of Physicians-American Society of Internal Medicine, Philadelphia, PA, USA. European Federation of Internal Medicine Gunilla Brenning, University Hospital, Uppsala, Sweden; Christopher Davidson, Royal Sussex County Hospital, Brighton, UK; Philippe Jaeger, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland; Alberto Malliani, Università di Milano, Milan, Italy; Hein Muller, Ziekenhuis Gooi-Noord, Rijksstraatweg, Netherlands; Daniel Sereni, Hôpital Saint-Louis, Paris, France; and Eugene Sutorius, Faculteit der Rechts Geleerdheid, Amsterdam, Netherlands. Special consultants Richard Cruess and Sylvia Cruess, McGill University, Montreal, Canada; and Jaime Merino, Universidad Miguel Hernández, San Juan de Alicante, Spain.

Medical Professionalism Project

Clinical question"What treatments are available for hot flushes in women receiving tamoxifen?" A 62-year-old woman asked her radiation oncologist this question. She was taking tamoxifen as adjuvant treatment for node-positive breast cancer, but was experiencing persistent and frequent hot flushes. Search questionThe search question was refined to "What treatments can be added to tamoxifen to reduce the frequency or severity of hot flushes? What are the benefits and risks?" The ideal study to answer these questions is a randomised controlled trial that compares various treatments in women taking adjuvant tamoxifen for breast cancer and prospectively assesses changes in flushing. SearchWe used a comprehensive strategy to search electronic databases, including MEDLINE, the Cochrane Library and SUMSearch <http://sumsearch.uthscsa.edu/searchform45.htm>. The search terms "hot flashes" / "hot flushes" and "tamoxifen" were combined to identify the relevant trials. Summary of findingsSeven agents have been tested in randomised, placebo-controlled trials. Appropriate randomisation procedures included stratification for tamoxifen use where applicable. Sample sizes ranged from 85 to 194 women, and the duration of baseline and evaluation periods ranged from 4 to 7 days and 28 to 84 days, respectively. Concurrent tamoxifen was an eligibility requirement in two studies, but otherwise between 59% and 81% of women were taking tamoxifen. Each study used frequency of hot flushes, as well as "activity scores" (which incorporate frequency and severity of flush episodes), to evaluate the medications. These were assessed using daily patient diaries, with a similar format in each study. Megestrol acetate (40 mg/day),1 venlafaxine (37.5–150 mg/day),2 transdermal clonidine (at a dose eqivalent to 0.1 mg/day orally)3 and oral clonidine (0.1 mg/day)4 were all significantly more effective than placebo at reducing the frequency of flushes after four weeks (P < 0.05). They resulted in reductions in the median number of flushes by 73%, 30%–58%, 44%, and 34% from baseline levels, respectively (ie, 4.5–2.7 fewer flushes daily from baselines of 6.1–8.0). The activity scores showed greater percentage reductions. Oral clonidine was also effective at eight weeks, but long-term effectiveness was not examined in any study. The three other agents examined — soy phytoestrogens,5 vitamin E6 and a "herbal remedy" black cohosh (Cimicifuga sp.)7 — were found not to be useful. Hormone replacement therapy is an established treatment for postmenopausal flushing. However, no randomised trials assessing its value in patients receiving tamoxifen for breast cancer were identified. Its safety in women with a history of breast cancer is controversial and it cannot be routinely recommended.8 Adverse reactions greater than those with placebo1-4 were, for megestrol acetate — withdrawal menstrual bleeding (31%); for venlafaxine — dry mouth, anorexia, nausea, and constipation; for oral clonidine — difficulty sleeping (41%); and for transdermal clonidine — itchiness under the patch, drowsiness, dry mouth and constipation. Each side effect may be dose-dependent. Each medication also has a number of recognised contraindications and precautions. OutcomeEach of the medications assessed in randomised trials is a reasonable option for treatment. However, venlafaxine's sole indication on the Pharmaceutical Benefits Scheme is major depression, while transdermal clonidine is not available in Australia. The radiation oncologist discussed the available choices with his patient. She declined venlafaxine on the basis of cost, and both megestrol acetate and clonidine on the basis of potential side effects, but continued to take tamoxifen.

Sean A Bydder MB ChB, FRANZCR · Nigel A Spry MB BS, FRANZCR

Any new patient with suspected genital herpes should have diagnostic testing with virus identification. Type-specific serological tests that distinguish between antibodies for type 1 and type 2 herpes simplex virus (HSV) may be useful to determine previous exposure but cannot be used to diagnose recurrences of genital herpes. Initial episodes of genital herpes usually require antiviral therapy, while recurrences may be treated with continuous antiviral suppression (if frequent) or episodic therapy; patient counselling and education (including how to recognise lesions) are essential. Topical or systemic therapy is available for initial and recurrent non-genital herpes simplex. Primary varicella infection (chickenpox) and herpes zoster (shingles) are usually diagnosed clinically, but can be confirmed by detection of varicella–zoster virus antigens or nucleic acid from swabs of lesions or by antibody tests. Antiviral therapy should be considered in chickenpox if disease is complicated or the patient is immunocompromised. In herpes zoster, antiviral therapy should be given within 72 hours of onset to patients aged over 50 years or with severe pain or neurological abnormalities to reduce the likelihood and duration of postherpetic neuralgia.

Dominic E Dwyer MD, FRACP, FRCPA · Anthony L Cunningham MD, FRACP, FRCPA

Henry Hudson was born in Santiago, Chile, on 2 February 1933. He studied medicine at the University of Chile, graduating in 1959. In the same year he began a residency at the Institute of Neurosurgery in Santiago under Professor A Asenjo, cofounder of the prestigious Journal of Neurosurgery. From 1966, under a British Council scholarship, he did postgraduate work in neurosurgery at the University of Edinburgh, Queen's Square Hospital (London) and the Radcliffe Infirmary (Oxford). In 1969, Henry returned to the Institute of Neurosurgery in Chile as a neurosurgeon. Two years later, the worsening political and economic situation in Chile led him to accept an invitation to come to Australia to work as a Neurosurgical Registrar at Sydney's Royal Prince Alfred Hospital. In 1974, he gained Fellowship of the Royal Australasian College of Surgeons in Neurosurgery, and in the following year began work at Concord Hospital (at the time, primarily a hospital for war veterans). It was at this hospital, with numerous patients suffering from back problems, that, 10 years later, he began to develop a unique specialty in microneurosurgery of the spine. By 1994, he was Head of the Department of Neurosurgery, but he retired in April of that year to work full-time on the development of microneurosurgery of the spine at the Mater Misericordiae Hospital in North Sydney. Using the operating microscope, specially developed surgical instruments and a rigid diagnostic protocol, Henry (with supporting radiologists) was able to precisely locate compressed nerve roots in the lateral recess of the spine and decompress them in a manner that was minimally invasive to the surrounding muscles and tissue. He took a keen interest in developments of the procedure in the United States and Europe, where it has become the procedure of choice. By limiting the size of the incision and reducing the operative damage to the paravertebral muscles, he enabled his patients to recover with less pain and at a much faster rate than they would have after conventional surgery. The procedure reduced postoperative complications from the usual 4% to around 1%. It was of particular value for patients who were elderly or unwell, and revitalised the careers of many professional footballers. Henry died of cancer on 4 November 2001 and is survived by his wife, Ana Maria, and children Paul, Henry and Mary Ann. To the end he was a caring man, a humanitarian, a brilliant surgeon and a true gentleman, who deserves his place in the annals of medical history. He was made a Member of the Order of Australia posthumously in the 2002 Queen's Birthday Honours list for "service to neurosurgery, particularly as a pioneer of minimally invasive surgical techniques for spinal conditions".

Paul Hudson

To the Editor: The article by Bellomo et al,1 with its alarmist conclusions, received a lot of media attention. However, the authors' methodology is flawed and their conclusions are unsupported by their data. They describe postoperative adverse events in a group of largely elderly patients (median age, 65.5 years) who stayed in hospital more than 48 hours after inpatient surgery. These selective criteria were used "to exclude patients having day surgery or minor procedures". Stratifying the severity of operations according to duration of stay is fundamentally flawed. This would have excluded many major, short-stay operations if the patient had had an uneventful postoperative course (eg, laparoscopic cholecystectomy and complex endoscopic procedures), and included others simply because a complication prolonged the patient's stay. The result is a selective bias towards a high complication rate. A more valid approach would have been to stratify all inpatient operations by severity and to include all major operations in the denominator for the study. This strategy would undoubtedly have shown significantly lower complication and mortality rates than those reported by Bellomo et al. The "silent epidemic" referred to in the study is neither silent nor an epidemic. An epidemic refers to a disease normally absent but liable to outbreaks. What the authors describe is an endemic situation (habitually present, of common occurrence); it is quite obvious and already extensively documented. Elderly patients undergoing major operations (especially in an emergency — "unscheduled surgery" in the authors' pejorative lexicon) are likely to have complications, and, when they do, need to stay in hospital longer. The authors did not analyse whether the adverse events were preventable, and therefore they cannot justify their conclusion that "there is much scope for improving postoperative care".

Thomas B Hugh · G Douglas Tracy · Rinaldo Bellomo · Donna Goldsmith · Sarah Russell · Shigehiko Uchino

To the Editor: The information in the article by Bellomo et al,1 which documents postoperative serious adverse events in a teaching hospital, contains no surprises; nor does it support some of the authors' conclusions. In 1995, the findings of the Quality in Australian Health Care Study2 were immediately sensationalised by the press with the headline "Hospital errors kill 18 000 a year".3 The article by Bellomo and colleagues provoked similar predictable media sensation. As acknowledged by the authors, the study addressed neither the causes of the serious adverse events, nor whether they were "preventable". Furthermore, the authors fail to show how their findings "suggest that there is much scope for improving perioperative care in our tertiary hospitals", or why "this is a 'silent' epidemic which requires urgent and systematic attention". However, in televised interviews, they made no effort to reduce the alarm aexpressed at the prevalence of errors. They have invented a new designation of "unscheduled surgery" (which presumably refers to acute, urgent or emergency admissions), preferring a title that suggests an avoidable lack of scheduling. It is hardly surprising that this group of patients required most of the admissions to the intensive care unit for which no prior booking had been made. It is unclear why the authors mention that "six of nine patients over 92 years of age having hip surgery died". Again, one presumes that these operations were for hip fracture, a condition with 100% mortality if untreated. And why leave out patients aged between 90 and 92 years? No amount of statistical manipulation conceals the bias that is obvious in their article. It might provide a media story, but it has minimal value for the critical reader.

Thomas B Hugh FRCS, FRACS · G Douglas Tracy · Rinaldo Bellomo MD, FRACP · Donna Goldsmith RN · Sarah Russell RN, PhD · Shigehiko Uchino MD

In reply: We thank Tracy and Hugh for the issues they raise. The goal of our study was to establish baseline information on the incidence of serious adverse events (SAEs) for use in subsequent intervention studies.1 The data were needed for statistical power calculations. Our inclusion criteria were predefined, as is scientifically orthodox for any study. We chose to study a population of clinical relevance to inpatient medicine. Most simple procedures at our hospital require day admission with no overnight inpatient stay, so these were not relevant to our goals. Others may wish to study different patient populations and are free to do so. In our opinion, there was no particular bias in our study, just accurate, prospective documentation of events. We used the term "unscheduled surgery" because it is verifiable and objective. An operational definition is necessary; otherwise, judgements about what is a true emergency (like judgements about what is preventable) are very dependent on observer bias. Nonetheless, according to our judgement, only 48 of 426 "unscheduled" operations were true emergencies. We wanted to identify groups that were at particular risk of death, hence the mention of patients over 92 years of age who had had hip surgery. Up to what level of expected postoperative mortality does it remain acceptable to perform major surgery in very elderly patients? We stand by our opinion that we are dealing with a silent epidemic. It is silent because we could find no previous prospective studies of SAEs for all major operations published (in English) in the medical literature, and there was no systematic plan to tackle them. We use the term epidemic because (in the absence of objective documentation of rates of SAEs in the past) our impression is that this is a growing phenomenon, related to the increased use of major surgery in the elderly. We also consider that only the absence of SAEs would offer no scope for improvement. A rate of SAEs of 16.9% should, logically, offer much scope for improvement. Whether such improvement can be realised remains a matter for future interventional investigations.

Thomas B Hugh

To the Editor: The article on acute community-acquired meningitis and encephalitis by Beaman and Wesselingh1 provides a comprehensive and up-to-date review of diagnostic and management issues relevant to general clinicians. However, the section on vaccines for preventing meningococcal C and pneumococcal diseases is not as contemporary. Contrary to the authors' statements that "a conjugate vaccine covering serogroup C [meningococcus] will be available in Australia shortly", and "a conjugate vaccine [for pneumococcus] is currently under trial in Australia", conjugate vaccines for both diseases are available and registered for use in Australia. Conjugate vaccines have the advantage that they can be used in children from six weeks of age and are expected to provide long-term protection. Meningitec is a meningococcal group C conjugate vaccine approved for use in children from six weeks of age, adolescents and adults. Meningitec has been available from Wyeth Australia since October 2001, but is not part of the National Childhood Immunisation Scheme and, as such, can only be obtained on private prescription at present. Prevenar (pneumococcal septavalent conjugate vaccine) is also approved for use and has been available from Wyeth Australia since January 2001. Prevenar is indicated for active immunisation of infants and children from six weeks to nine years of age against invasive disease, pneumonia and otitis media caused by Streptococcus pneumoniae.

Deborah C Saltman · Miles H Beaman · Steven L Wesselingh

In reply: We thank Saltman for up-to-date information on Wyeth vaccines. Readers will appreciate that our article1 was commissioned in January 2001, and the manuscript delivered in August that year, before the licensing of Meningitec. As the article discussed, group C meningococcus is a minority strain in most regions of Australia. Hence, the vaccine will not prevent most cases of what is already an uncommon disease. Conjugate pneumococcal vaccines should have much wider application in the future, but currently are subsidised for use in only a minority of the at-risk population.

Deborah C Saltman MD, FRACGP, FAFPHM · Miles H Beaman FRACP, FRCPA · Steven L Wesselingh FRACP, PhD

To the Editor: As noted in the letter by Chapman and Jamrozik,1 there was substantial prescribing of bupropion sustained release (Zyban SR; GlaxoSmithKline) following its Pharmaceutical Benefits Scheme (PBS) listing from 1 February 2001. The drug has been the subject of extensive publicity following reports of adverse drug reactions and deaths of patients while taking bupropion. Although bupropion has been shown to be effective in two key clinical trials,2,3 there are no studies of effectiveness when prescribed in the context of Australian general practice. We conducted a study of short-term effectiveness involving 11 general practice registrars working in eight practices in south-west and southern Sydney. Each registrar identified from practice prescribing records 10–15 patients prescribed bupropion after 1 February 2001. These patients were followed up via a telephone questionnaire 10 weeks after the date of prescription. The questionnaire elicited information on the use of bupropion, patient-reported abstinence rates, adverse effects and use of support services. Biochemical validation of smoking status was not conducted. Interviews with 151 patients were conducted between April and August 2001 (see Box). Patients completing seven weeks or more of therapy were significantly more likely to report both continuous abstinence (P = 0.01) and point-prevalence abstinence (P = 0.002). Eighty-three patients reported adverse effects, the five most common being insomnia (14%), headaches (11%), nausea (8%), dry mouth (5%) and irritability (4%). No convulsions were reported. Patients who made use of one or more support services for cessation counselling were no more likely to report point-prevalence abstinence at follow-up than those who did not (P = 0.8). Our study was not based on a random sample of GPs or patients, and we did not collect data on the total number of patients treated with bupropion in these practices over the study period. Bearing in mind these limitations, the study has a number of notable findings. Despite the wording of the PBS authority "for use within a comprehensive treatment program'', fewer than half the patients reported using any support service. There was also a low rate of completion of the recommended course of treatment (less than 20% of patients). While the short-term abstinence rates among the patients followed up were encouraging, and not dissimilar to rates found in clinical trials,2,3 there is clearly a need to look at strategies to encourage patients to adhere to the prescribed course of treatment and to make use of cessation support services. We suggest patients be invited back for at least two follow-up GP visits following prescribing of bupropion, as well as being made aware of other support services. Ten-week follow-up survey of patients prescribed bupropion sustained release (Zyban SR) for smoking cessation (n = 151) Patients taking all or part of course of drug therapy 124 (82%) Mean duration of therapy (weeks) 4.6 (range, 1–12) Patients completing at least seven weeks of therapy 24 (19% of those who took all or part of course) Patients reporting continuous abstinence at 10 weeks 47 (31%) Patients reporting point-prevalence abstinence at 10 weeks 57 (38%) Patients reporting adverse effects 83 (68% of those who took all or part of course) Patients accessing one or more support services (general practitioner, Quitline, ZAP*) 69 (46%) *ZAP = Zyban Action Plan (trademark of GlaxoSmithKline)

Nicholas A Zwar · Alia Nasser · Elizabeth J Comino · Robyn L Richmond

To the Editor: In November 1999, the National Health and Medical Research Council (NHMRC) released Guidelines for the prevention, early detection and management of colorectal cancer.1 One chapter addressed screening for colorectal cancer (CRC), citing Level 1 evidence in support of faecal occult blood testing (FOBT) as the preferred modality for population-based CRC screening. Colonoscopy and sigmoidoscopy were not recommended. In a postal survey conducted in 1998, before release of these guidelines, we found mixed views among Australian surgeons about CRC screening.2 In February 2001, we conducted a follow-up (post-guidelines) survey which included three questions about CRC screening that had been asked in the pre-guidelines survey. Using a pre–post design, we evaluated the impact of the NHMRC guidelines on surgeons' views. Of the 172 surgeons confirmed still to be in active practice at the time of follow-up, 114 (66%) returned questionnaires. One hundred and three (90%) agreed to matching of their baseline and follow-up responses. Of these, 101 (98%) provided valid responses to each of the three questions on both occasions. Surgeons' views about population-based CRC screening by FOBT changed significantly between the surveys (Box). At baseline, half "strongly agreed" or "agreed" that population-based FOBT should be introduced for all Australians over the age of 50 years. At follow-up, the proportion had increased significantly to more than two-thirds (McNemar's χ2 = 13.0; P < 0.001). There was no significant change in the percentage of surgeons who "strongly agreed" or "agreed" that colonoscopy is preferable to FOBT (McNemar's χ2 = 0.9; P = 0.3). In contrast, there was a significant decrease in the percentage who "strongly agreed" or "agreed" that sigmoidoscopy is preferable to FOBT (McNemar's χ2 = 4.4; P = 0.04). Although the influence of events unrelated to the NHMRC guidelines cannot be entirely excluded from uncontrolled evaluation designs such as this, our data provide some reassurance that the guidelines have had an impact. However, as argued elsewhere,3 substantially more effort is required to ensure that patients with CRC detected through screening receive evidence-based management. More rigorous study designs with control groups are recommended to identify strategies effective in changing surgical practice. Finally, surgeons' increased enthusiasm for CRC screening contrasts with public hesitancy.4 Surgeons' views about screening for colorectal cancer before and after publication of national guidelines1 (n = 101) Strongly agree Agree Neutral Disagree Strongly disagree Population-based screening by FOBT should be introduced for all Australians over 50 years of age Before After 17% 26% 34% 44% 28% 23% 18% 8% 4% 0 Colonoscopy is preferable to FOBT as a population-based screening method Before After 6% 7% 23% 28% 21% 22% 42% 37% 9% 7% Sigmoidoscopy is preferable to FOBT as a population-based screening method Before After 2% 1% 23% 13% 13% 23% 55% 55% 8% 9% FOBT = faecal occult blood testing. Due to rounding, row percentages do not necessarily sum to 100%.

Annie Cooney · Neil J Donnelly · Melina Gattellari · Jeanette E Ward

To the editor: Large randomised trials have confirmed that treatment with cholecalciferol (vitamin D3) and calcium reduces hip and non-vertebral fractures.1,2 In public health terms, calciferol compounds are cost-effective,3 simple to monitor and generally free of side effects. Ergocalciferol (vitamin D2) is the only single prohormonal form of vitamin D available in Australia.4 As compliance rates for this medication have not, to our knowledge, been evaluated, we decided to conduct our own study of compliance. At the Royal Perth Hospital, between June and September 2001, we identified 106 people with hip fracture who were vitamin D insufficient (defined as a serum 25-hydroxyvitamin D level < 50 nmol/L) and began treatment with ergocalciferol. Three months after discharge, we interviewed patients to determine whether they were complying with treatment and, if not, the reasons for non-compliance. Of the 106 patients identified, 53 were interviewed (the remaining 53 patients were not contacted for various reasons: 38 did not live in the metropolitan region, eight had died, one refused interview and six were lost to follow-up). Of the patients interviewed, 33 (62%) had complied with therapy. Reasons for non-compliance among the remaining 20 (38%) are outlined in the Box. Reasons for non-compliance with vitamin D therapy Reason Number of patients Not on discharge script from orthopaedic ward/ Reason for taking medication unknown by patient and/or carer 9 Stopped by general practitioner or doctor from another hospital/ Not continued after hospital supply used up 6 Patient refusing all medication/ Patient moribund 4 Side effects/ Intolerance of medication 1 The most common reason for non-compliance was poor communication between the hospital and the general practitioner. The second most common cause of non-compliance — failure to continue treatment on discharge or active cessation by the attending physician following discharge — indicates either that medical practitioners are ambivalent about the treatment of vitamin D deficiency or that patient-specific factors are at work. Ergocalciferol is not listed under the Pharmaceutical Benefits Scheme. It is available directly from pharmacy outlets without a prescription and the cost of treatment (currently about $17.50/month for 60 × 1000 IU tablets) must be borne entirely by the patient. Thus, continuation of treatment is largely dependent on patient initiative, and, in our survey, cost may have been a disincentive to continue the medication once the hospital discharge supply was depleted. Side effects of the medication were a very minor reason for non-compliance — only one patient out of 20 stopped therapy because of ergocalciferol intolerance. Our audit had several limitations: the sample size was small, treatment was not blinded, and only patients living within the inner Perth metropolitan area were interviewed, which may have introduced bias. Vitamin D deficiency remains a common and undertreated cause of osteoporotic hip fracture in elderly people, both in Australia and elsewhere.5 Our study suggests that the rate of non-compliance with ergocalciferol therapy is unacceptably high.

Jane M Noble · Marjory McGuiness · Paul Glendenning

Re the letter "Guidelines for the management of gestational diabetes mellitus revisited", by David S Simmons, Barry N J Walters, Peter Wein and N Wah Cheung, on behalf of the Australasian Diabetes in Pregnancy Society, published in the 1 April issue (Med J Aust 2002; 176: 352), in which the American College of Obstetricians and Gynecologists criterion for diagnosing gestational diabetes mellitus of a 1-hour fasting plasma glucose level of ≥ 10.0 mmol/L was mistakenly placed in the adjacent Australasian Diabetes in Pregnancy Society column. The entire corrected table is reprinted below. Differences between management guidelines for gestational diabetes mellitus (GDM) from the Australasian Diabetes in Pregnancy Society (ADIPS, 1998) and the American College of Obstetricians and Gynecologists (ACOG, 2001) ADIPS ACOG Universal versus selective screening by blood test Universal unless low GDM incidence or resources limited No recommendation. States that "many physicians elect to screen all pregnant patients as a practical matter" Differences in definition of low risk for GDM Age < 30 years, obesity, family history of diabetes Age < 25 years, body mass index < 25 kg/m2. No known diabetes in first-degree relative Oral glucose tolerance test used 75 g, 2-hour, 2-point blood sampling 100 g, 3-hour, 4-point blood sampling Criteria for diagnosis of GDM Plasma glucose level: Fasting, ≥ 5.5 mmol/L and/or 2-hour, ≥ 8.0 mmol/L Plasma glucose level: Fasting, ≥ 5.3 mmol/L; 1-hour, ≥ 10.0 mmol/L; 2-hour, ≥ 8.6 mmol/L; 3-hour, ≥ 7.8 mmol/L (2 or more time points need to elevated) Insulin therapy commenced after medical–nutrition therapy Plasma glucose level: Fasting, ≥ 5.5 mmol/L and/or 1-hour postprandial, ≥ 8.0 mmol/L and/or 2-hour postprandial, ≥7.0 mmol/L Plasma glucose level: Fasting, ≥ 5.3 mmol/L and/or 1-hour postprandial, ≥ 7.2–7.8 mmol/L and/or 2-hour postprandial, ≥ 6.7 mmol/L

David S Simmons · Barry N J Walters · Peter Wein · N Wah Cheung

Evidence-based coronary care. Mark Connaughton. London: Churchill Livingstone, 2001 (xxii + 195 pp). ISBN 0443 06415 6. Clinicians working in the area of coronary care have the luxury of an enormous evidence base to guide their decision-making. Many of the so-called megatrials which have defined the modern era of evidence-based medicine were designed to answer important questions in acute coronary care. Making use of this evidence and applying it to patient care is a daily challenge for staff working in coronary care units. Mark Connaughton has done an excellent job in marshalling the evidence in a readable form and presenting it in a format which is easy to follow. On the left-hand page, concise recommendations are presented. On the right-hand page there is a summary of the published evidence, together with the key references. The reader obtains an immediate perspective on what is known and not known from the evidence. If the evidence is missing, the right-hand page is blank. This sensible and usable format could serve as a model for the presentation of clinical practice guidelines in general. The management of acute coronary syndromes is an area of rapid developments, so there are bound to be limits on the data presented. For instance, the statement “optimal strategies for managing unstable angina pectoris have not been determined and are an area of considerable current interest” has been rendered obsolete by recent trials and the development of detailed guidelines from the United States, Australian and European cardiac societies and heart associations. Unfortunately, the excellent format of the book is not followed in section 7. Here the author breaks his own rule by presenting tables, comments on electrocardiogram interpretation and “principles” on the right hand page which are not supported by published evidence. While there is much talk about downloading concise guidelines onto personal digital assistants (PDAs), this approach is limited by the fact that many junior medical and nursing staff do not have their own PDAs. Until the digital revolution has progressed to universal ownership of PDAs, Evidence-based coronary care is a neat solution to bringing evidence-based practice to the bedside of the patient with an acute coronary syndrome. Peter L ThompsonCardiologist Sir Charles Gairdner Hospital, Perth, WA

Peter L Thompson

Cases in surgical radiology. David C Howlett and Michael P Saunders. Oxford: Blackwell Science, 2001 (ix + 220 pp). ISBN 0 632 05822 6. The presentation of radiological images is an excellent method for teaching all aspects of medicine to students and advanced trainees. It provides an introduction to the condition under examination and acts as a springboard for further discussion. Cases in surgical radiology is a published version of this commonly utilised teaching technique. It is set out as a series of tutorials constructed by nine consultant radiologists from Eastbourne, Guy’s and St Thomas’s hospitals in the United Kingdom and Vancouver General Hospital in Canada. Each “tute” consists of 12 diverse surgical cases, including radiographs, computed tomography (CT), ultrasound, contrast studies, occasional magnetic resonance imaging (MRI) and nuclear medicine scans, and is set out as a brief clinical history and accompanying radiological study. The reader is asked a series of questions based on these studies. Image interpretation is provided on the following page, together with further imaging and a clinical perspective such as differential diagnosis. Follow-up reading on the subject is facilitated by the inclusion of a literature or textbook reference. The book works and is fun. The format is simple and concise, and this pocket size, soft-cover book is easy to whip out and read when a spare moment arises. It is not a comprehensive text for the on-call surgical or radiology registrar, although it does have a reasonable index allowing for review of a specific pathological condition. My only complaints are that the contributors have delved a little too deeply into their teaching files, producing one or two cases that are quite esoteric, and that photographic reproduction, especially for the abdominal radiographs, is not always optimal. I have no hesitation in recommending this book for a medical library catering to students or surgical trainees. Given that it is reasonably cheap, it would also be a good buy for individuals. In summary the concept is excellent, the format well executed and the cases instructive. It is a useful resource for the teaching of surgery through the interpretation of radiological studies. Christopher J O’DonnellRadiologist, Brighton East, VIC

Christopher J O’Donnell

Statistical methods for anaesthesia and intensive care. Paul Myles and Tony Gin. Oxford: Butterworth-Heinemann, 2000 (viii + 152 pp). ISBN 0 7506 4065 0. For some time I have pondered on how a statistician chooses one method of analysis over another for a research project. One time it’s the Student’s t test and the next it’s ANOVA. Words such as parametric and non-parametric have always sounded quite “scientific”, but had no real meaning in my limited understanding of research methods. This book has changed all that. I can now recite definitions for confidence intervals, relative risks and odds ratios, but, more importantly, I can make more sense of the research I am trying to use to improve health outcomes for my patients. Thirteen clear and concise chapters demystify how medical research data are described and analysed. Simple, worked examples illustrate the principles elegantly and effortlessly. Just a couple of hours will have you well on the way to understanding statistical methods used in health research. No longer will you have to say to yourself “I should know that” — you will “know that”. This would be a good book to consider using for Continuing Medical Education, Maintenance of Professional Standards and for all doctors in training. Why keep this little gem just for the intensivist and anaesthetist? It’s fantastic! Sue InglisDirector of Rehabilitation Alwyn Private Hospital, Strathfield, NSW

Sue Inglis

Bound to bounce Getting out of hospital in time for the weekend might seem like a good idea, but Canadian researchers warn that a Friday discharge does not necessarily produce the best outcome. A search of Ontario’s hospital Discharge Abstract Database revealed 2 403 181 patients discharged after non-elective admissions between 1990 and 2000. In the 30 days after discharge 1.7% of all patients died and 5.4% were readmitted. Friday was the most popular day for discharge, but, even after controlling for multiple demographic and clinical factors, patients discharged on Fridays had a small but significantly increased risk of death or readmission (hazard ratio, 1.04, compared with those discharged on Wednesdays). CMAJ 2002; 166: 1672-1673 Prospects for paternity The good news for male survivors of childhood cancers is that, although their sperm production may be markedly decreased, the sperm that are produced appear to carry a normal amount of healthy DNA. Researchers in Edinburgh recruited 33 men (median age, 21.9 years) who had been treated with chemotherapy and/or radiotherapy for a range of childhood cancers diagnosed at a mean age of 10 years, and two age-matched controls for each patient. As well as performing semen analysis, they measured the extent of DNA fragmentation in spermatozoa. About a third of the cancer survivors had normal semen quality, 10 were azoospermic, six had sperm concentrations of < 20 × 106/mL, and the median sperm concentration among those with any sperm was significantly lower than that of the control group. However, there was no significant difference between the groups in sperm DNA integrity. The findings suggest that cancer survivors who become fathers using assisted-reproduction techniques such as intracytoplasmic sperm injection do not have an increased risk of genetic damage in their offspring. Lancet 2002; 360: 361-367 Negative growth A British study has raised concerns that patients who have been treated with human pituitary growth hormone (PGH) may be at increased risk of certain cancers, but the link is far from definite. Between 1959 and 1985, 1848 children and adolescents in the UK received human PGH. By 1995, 12 people had developed cancer (excluding non-melanoma skin cancers and neurological tumours) and by December 2000 there were 10 cancer deaths, giving a standardised mortality ratio of 2.8 compared with the matched general population. Two deaths each from colorectal cancer and Hodgkin’s disease were reported (compared with 0.18 and 0.85 deaths expected, respectively). Human PGH was replaced by a synthetic form of the hormone in 1985, after the risk of Creutzfeldt–Jakob disease was identified. Dosage regimens differ from those used previously and any carcinogenic potential of current therapy remains unexplored. Lancet 2002; 360: 273-277 Wanted — dead or alive Given the current worldwide shortage of organs for transplant, it is interesting to note the findings of a Swiss study, which shows that renal grafts from donors without heartbeats do as well as those from brain-dead donors with heartbeats. Between 1985 and 2000, 122 (10.8%) of the 1133 renal transplants at the University Hospital, Zurich, involved donors without heartbeats. When compared with 122 recipients of kidneys from donors with heartbeats (matched for sex, age and year of transplantation), patients in this group were more likely to require dialysis in the first week after transplantation (48.4% v 23.8%). However, the rates of long-term graft survival were similar (83.7% v 82.3% at five years, and 78.7% v 76.7% at 10 years). All of the donors without heartbeats were alive on arrival at hospital: most (80.3%) died as a result of trauma. N Engl J Med 2002; 347: 248-255 Sweat it out Evidence is mounting for the therapeutic role of aerobic exercise in fibromyalgia. A randomised controlled trial in the United Kingdom compared two community-based programs for the condition. Researchers identified 136 patients from letters sent to GPs by rheumatology clinics over an 18-month period, and assigned the patients to participate in either aerobic exercise or relaxation and flexibility classes at a local “healthy living centre” twice weekly for 12 weeks. There was a high overall dropout rate (72 patients attended more than a third of the classes). However, patients assigned to the aerobic exercise group were significantly more likely than those in the relaxation group to report being much or very much better, both at three months (35% v 18%, respectively) and 12 months (38% v 22%). Examination at 12 months also revealed a decrease in the number of tender points (of the 18 sites specified in the fibromyalgia diagnostic criteria) in both groups. Only 31 of 69 patients in the exercise group and 44 of 67 patients in the relaxation group still met the diagnostic criteria for fibromyalgia. BMJ 2002; 325: 185-187