Volume 190 Issue 9

Challenging the assumption that higher rates of intervention provide no benefits for babies Hardly a week seems to pass in Australia without an article in national newspapers drawing attention to the differences in obstetric intervention rates between private patients cared for by obstetricians and public patients who receive various models of care.1 The reported assumption has consistently been that the higher intervention rates observed in private patients are of no benefit to women or their babies, and possibly cause harm. This opinion has inevitably led to suggestions that federal support for private obstetric care be scaled back and redirected to models of care with lower intervention rates.2 An article by Robson and colleagues in this issue of the Journal reporting the results of a review of births in Australia (Adverse outcomes of labour in public and private hospitals in Australia: a population-based descriptive study)3 thus achieves increased significance by being published at a time when the federal Health Minister has received and is preparing her response to the report of the Maternity Services Review.4 Robson and colleagues report a retrospective analysis of the 789 240 singleton births occurring between 37 and 41 weeks’ gestation in Australia during 2001–2004, excluding about 15% of pregnant women for methodological reasons.3 Outcomes reported in the National Perinatal Data Collection (NPDC) were adjusted for recorded risk factors. Their study confirms increased intervention rates in private patients. A previous study by Roberts and colleagues reporting higher instrumental delivery rates for low-risk private patients found a higher risk of low Apgar scores in babies of public patients,5 which might have implied a possibility of poorer outcomes for these babies, but perinatal mortality and morbidity data were otherwise lacking. Robson et al’s study demonstrated a twofold increase in risk of perinatal death for babies delivered in public hospitals, as well as significant increases in risk of low Apgar scores, need for high-level resuscitation, and admission to a special care or neonatal intensive care nursery. Of the two maternal outcomes available in the NPDC, only perineal trauma was reported, and, somewhat unexpectedly given the higher rate of instrumental deliveries in private patients, the rate of third- and fourth-degree lacerations was lower in private patients (also confirming the findings of Roberts et al’s study5). Unfortunately, incomplete data precluded reporting of maternal blood loss, and the NPDC does not report other maternal complications. This situation should hopefully be addressed in the future by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists’ planned maternal morbidity audit. So what can we learn from this study? It is always more difficult to rely on retrospective data, especially when gathered from populations with different sociodemographic factors, even when adjusting as far as possible for known risk factors. However, unless we are to conduct randomised controlled trials of private versus public models of maternity care (unlikely) or planned caesarean versus planned normal delivery (even more unlikely), the quality of these data is as good as any we are likely to obtain. It is worth noting that in restricting their analysis to women with singleton pregnancies delivered between 37 and 41 completed weeks’ gestation, Robson et al minimise the bias that follows from the fact that women with preterm deliveries, which are at highest risk of perinatal morbidity, are generally transferred when possible to tertiary referral centres in the public system. However, failure to similarly exclude outcomes for predictably high-risk pregnancies delivered at term at these centres (eg, babies with antenatally diagnosed major congenital abnormalities) introduces a numerically small but possibly significant bias towards a relatively higher risk of adverse outcomes in the public patient group. Adjusting for other known risk factors also minimises to the extent possible the differences in outcomes attributable to different prevalences of these risk factors in populations of differing socioeconomic background, but cannot eliminate them altogether. Notably, some of these socioeconomic differences would be expected to increase the risk for babies of private patients (higher proportions of primigravidae, maternal age of 40 years or older, and history of previous caesarean delivery). In addition, the exclusion of babies delivered after 41 completed weeks’ gestation is likely to reduce the rate of adverse outcomes in the public patient group, as allowing pregnancies past 41 weeks — when perinatal mortality is 70% higher than for babies delivered at 40 weeks6 — is virtually unknown in private patients, but does occur in the public system. This study has inevitably generated some media controversy7 because for the first time there are national data, albeit with methodological limitations, to suggest that private obstetric care and its associated higher rates of intervention might actually be benefiting babies, if not their mothers. The study is silent on major maternal problems other than severe perineal trauma, which might be associated with the increased obstetric intervention rates associated with private care and especially with caesarean delivery (haemorrhage, hysterectomy, wound complications and venous thromboembolism). Is it possible to extrapolate the findings of this study to conclude that private care provided by obstetricians, with its increased intervention rates, prevents perinatal mortality and morbidity in Australia? No, but it must make us at least consider the possibility, and challenge the tacit assumption that continuity of care with a private obstetrician and/or higher intervention rates do not prevent perinatal morbidity and mortality. Historically, it was always assumed that a decision in favour of intervention (especially caesarean delivery) presented a balance of risks — babies benefited, but this benefit was bought at the cost of increased maternal risk. More recently, some studies have been published which suggest that babies born by caesarean delivery are actually at higher risk of adverse outcomes, including perinatal death.8 Robson et al’s study supports a return to the previous understanding that, in choosing obstetric intervention, clinicians and their patients need to balance the potential benefits for the baby with the risks borne by the mother.

Andrew F Pesce MB BS, FRANZCOG

Guidance for clinicians on how to interpret conflicting evidence from recent studies Patients with advanced chronic obstructive pulmonary disease (COPD) have profound functional impairment and increased mortality.1 Inhaled bronchodilators, including the anticholinergic agents tiotropium bromide and ipratropium bromide, relieve symptoms and improve lung function and quality of life. Tiotropium also reduces COPD exacerbations and hospitalisations.2 Recently, the safety of anticholinergics in patients with COPD has been questioned. Based on a pooled analysis provided by the manufacturers, the United States Food and Drug Administration (FDA) alerted clinicians to an increased risk of stroke with tiotropium.3 Furthermore, a meta-analysis by Singh and colleagues4 and a nested case–control study by Lee and colleagues5 have reported an increased risk of cardiovascular events and death in patients taking inhaled anticholinergics. Two background issues are relevant. First, with once-daily tiotropium, an improvement in lung function is maintained over time, whereas the respiratory effects of ipratropium wear off within 6 hours of each dose. It is therefore likely that their physiological effects outside the respiratory system are different. Also, the potential for overuse is greater with ipratropium, when taken as needed for symptom relief. Second, the presence of COPD is itself associated with an increased risk of cardiovascular death.6 Reasons for this are incompletely understood and controversial. Furthermore, except for long-term oxygen, no medications for treating COPD clearly improve survival. A recent study suggesting improved survival with inhaler treatment was not designed to answer this question and its results require confirmation.7 The meta-analysis by Singh et al (some results of which have recently been revised in a published correction4) studied 17 randomised controlled trials in which cardiovascular events were reported and that involved 13 645 patients in whom either anticholinergics (ipratropium or tiotropium) or control therapies were used for at least 30 days.4 It included data not available in previous meta-analyses. The primary outcome was a composite of cardiovascular death, myocardial infarction or stroke. This was more prevalent in the anticholinergic group, with a relative risk of 1.60 (95% CI, 1.22–2.10) and a risk difference of 0.007 (95% CI, 0.003–0.013). The secondary outcome was all-cause mortality, which was not statistically different between the two groups (the revised value given in the correction to the original study [P = 0.05] approaches, but does not reach, statistical significance). The nested case–control study by Lee et al used national databases to identify 32 130 cases (patients with COPD who died) and 10 times that number of controls (surviving patients with COPD) in the US.5 It showed an association of ipratropium use with both all-cause mortality (odds ratio [OR], 1.11; 95% CI, 1.08–1.15) and cardiovascular death (OR, 1.34; 95% CI, 1.22–1.47). Tiotropium was not examined in this study. Coincidentally, results of the largest and longest-running randomised controlled trial of tiotropium use — the UPLIFT trial — have also recently been published.8 This was a 4-year study investigating the clinical benefit of tiotropium and decline in lung function in 5993 patients with COPD. It found that in patients treated with tiotropium, there was no increase in cardiovascular death or stroke, myocardial infarction was less frequent, and there was a non-significant trend to lower all-cause mortality. These findings are in keeping with a meta-analysis conducted in 20062 and a large population study in 2007,9 but the prospective nature of the UPLIFT study gives it greater validity. How can these very different results be explained? Methodological weaknesses and differences in study design are probably a major factor. First, cardiovascular events and strokes were not defined a priori in any of the studies, raising the possibility of inaccurate data collection. In this setting, all-cause mortality is likely to be more reliable. Second, both the UPLIFT trial and Singh et al reported very high discontinuation rates. A third methodological weakness is the presence of confounders; for example, Lee et al’s study was not able to eliminate or adjust for the crucial confounders of COPD severity and smoking status. Finally, study populations differed. In the UPLIFT study, the rate of ongoing smoking was low and the use of other concurrent COPD medication probably higher than in most of the studies analysed by Singh et al — both these factors may be cardioprotective. How does one act on this conflicting and partially flawed safety data? Regarding tiotropium specifically, no study has shown an increase in all-cause mortality. In the studies performed so far, all-cause mortality is likely to be a more robust outcome than death due to cardiovascular or respiratory causes. Even if the increase in cardiovascular events with tiotropium reported by Singh et al is correct, the size of the effect is small, and the unchanged all-cause mortality suggests that another specific cause of death has decreased. Singh et al did not report respiratory deaths, but some other studies have shown a decrease in these with tiotropium use,9 consistent with its beneficial effects on exacerbations and hospital admissions.8 The safety of ipratropium is less clear. The concerns raised by Singh et al are reinforced by Lee et al’s finding of increased all-cause and cardiovascular mortality with ipratropium use. No guidelines have yet incorporated these recent studies into their recommendations, and the FDA’s response based on its ongoing safety review is pending. In the interim, the use of tiotropium in patients with COPD is likely to be safe and beneficial. If a short-acting bronchodilator is desired, the cardiac risk profile of the patient must be considered because of the uncertain safety of both ipratropium and short-acting β2 agonists.10 Finally, the uncertainty about the safety of anticholinergics needs to be placed in the context of managing patients whose COPD presents major challenges related to their severe respiratory impairment and the increased risk of comorbidities such as lung cancer, depression and osteoporosis, as well as cardiovascular disease.

Mark J Hew MB BS, PhD, FRACP · Piersante Sestini MD · Louis B Irving MB BS, FRACP, FRACGP

Do you have patients who could benefit from therapeutic pacing and defibrillator devices? In recent years, management of chronic heart failure has advanced considerably, especially the optimisation of key pharmacological strategies (angiotensin-converting enzyme inhibitors, β-blockers) and multimodal management. In parallel, there has been a quieter revolution: the use of therapeutic pacing and defibrillator devices in patients with heart failure has moved from experimental and clinical research to everyday clinical practice. Milestones include landmark trials establishing the definitive mortality benefit of implantable defibrillators in ischaemic cardiomyopathy,1 the clinical utility of electronically synchronising contraction of both ventricles,2 and mortality benefits of cardiac resynchronisation therapy (CRT).3 Nonetheless, therapeutic pacing and defibrillator devices appear to be underutilised,4 perhaps due to lack of awareness of their clinical benefits and concerns regarding cost. What are the established modalities? Sudden cardiac death is a significant risk in patients with impaired left ventricular function. The use of implantable cardioverter defibrillators (ICDs) is established in primary and secondary prevention of sudden cardiac death in chronic heart failure — large randomised controlled studies have demonstrated a significant mortality benefit.1,5 American6 and Australian7 guidelines for heart failure management state that an ICD may be used after cardiac arrest, ventricular tachycardia or ventricular fibrillation; ≥ 40 days after myocardial infarction in patients with New York Heart Association (NYHA) class I, II or III symptoms and left ventricular ejection fraction (LVEF) ≤ 30%; and in patients with ischaemic or non-ischaemic cardiomyopathy, NYHA class II or III symptoms and LVEF ≤ 35%. Newer “risk stratifiers” are being explored to better identify patients likely to benefit from ICD therapy.8 The implantation procedure for an ICD is identical, in principle, to that of a pacemaker, with some exceptions: the lead is larger (thus stiffer), so care is required during its manipulation within the heart; the battery is larger, so it requires careful positioning to avoid skin erosion; and testing of the device involves inducing ventricular fibrillation to ensure adequate sensing of arrhythmia and an adequate safety margin in terms of the threshold of defibrillation. Also, the sophisticated programming of ICD therapy requires a cardiac electrophysiologist. ICDs can be programmed to treat ventricular arrhythmias with either antitachycardia pacing (which is painless) or shock therapy. After the patient experiences their initial therapy, which unfortunately may involve a potentially distressing shock while the patient is conscious, individualised adjustments may be needed. Despite the survival benefit associated with ICDs, their impact on quality of life is uncertain. In contrast to other heart failure therapies, ICDs do not improve cardiac function. They would not be expected to improve a patient’s exercise capacity or ability to perform activities of daily living. Also, implantation can be associated with various immediate and late complications, including device infection, failure and inappropriate discharge.9 The failing heart is frequently characterised by abnormalities of mechanical synchrony, often reflected by abnormalities of electrical conduction. Based on adverse consequences of ventricular dyssynchrony in heart failure, researchers have sought to resynchronise the failing myocardium. One approach, CRT, involves pacing both ventricles in a coordinated manner to restore the normal physiological chronology of left- and right-sided contraction. Ventricular dyssynchrony can be crudely detected on an electrocardiogram by QRS prolongation.10 Epidemiologically, QRS prolongation has been associated with worsening of clinical outcomes in patients with heart failure. Echocardiography has been proposed as a better tool for evaluating mechanical dyssynchrony.11 The implantation of a CRT device extends the standard pacemaker or ICD implantation procedure by placement of a left ventricular pacing lead. This requires specialised sheaths to access the coronary sinus, angiographic identification of an appropriate lateral branch, and careful positioning of the lead. Several factors determine the ideal position for the lead, including proximity to the lateral wall at a position furthest from the right ventricular lead, stability of lead placement, presence of viable myocardium that can be captured by pacing at the site, and avoidance of diaphragmatic pacing. The procedure requires an experienced operator and a service that can optimise programming. CRT has undergone considerable evaluation and, according to American and Australian guidelines, it is indicated in patients with NYHA class III or IV symptoms, LVEF ≤ 35% and QRS duration on electrocardiogram > 120 ms.6,7 More than 4000 patients have been evaluated in randomised single- or double-blind controlled trials of CRT in heart failure and, in systolic heart failure, CRT has consistently been associated with improved patient wellbeing and ventricular systolic function, and reduced recurrent hospitalisation for heart failure. Meta-analyses and a stand-alone study have shown reduced all-cause mortality with CRT.3,12 These benefits add to those of standard drug therapies for systolic heart failure, and may be further enhanced by use of a defibrillator. Indeed, most CRT devices used in Australia include a defibrillator function. Ideally, patients should be in sinus rhythm for maximum benefits from this therapy. Some evidence suggests that CRT is also beneficial in patients with atrial fibrillation, and that this cohort may be better optimised with atrioventricular node ablation.13 However, current Australian Government Department of Health and Ageing guidelines do not support the use of these devices in patients with atrial fibrillation.14 In addition, not all patients who meet the criteria for CRT benefit from the therapy. There is a 20%–30% “non-response rate”, in that patients do not feel better or ventricular function does not improve.14 The reason for this is elusive, but improved evaluation of dyssynchrony, using measures more sophisticated than QRS duration (eg, echocardiography, magnetic resonance imaging), may reduce the non-response rate, and CRT trials that base entry criteria on results of imaging alone are underway. Nonetheless, CRT has gained popularity in recent years, particularly for patients who remain severely symptomatic despite drug therapy. What other modalities are being evaluated? Cardiac contractility modulation (a new form of electrical therapy) is currently being evaluated in patients with heart failure. A recent clinical study demonstrated improved exercise tolerance and quality of life,15 but these data need to be confirmed in large, randomised controlled studies. Ventricular pacing alone has also been trialled, but can result in deleterious mechanical effects. In patients with impaired left ventricular function, right ventricular pacing can cause further deterioration.16 Adverse effects may be minimised by pacing the right ventricular outflow tract or high septum rather than the apex.17 Perhaps more importantly, atrioventricular synchrony can be maintained, and many pacemakers allow minimisation of ventricular pacing by various programmable algorithms. What is needed now? Over the past decade, many pacing therapies have been rigorously evaluated in patients with chronic heart failure, and there are now proven indications for their application in clinical practice. The clinical outcomes, potential problems and costs of CRT, ICD and right-sided pacing are summarised in the Box. Doctors should be aware of these therapies and consider referring individual patients who meet the criteria for their use. Comparison of some features of pacing modalities for chronic heart failure and comorbid arrhythmias Cardiac resynchronisation therapy Implantable cardioverter defibrillator Right-sided pacing Clinical outcomes Decreased mortality, morbidity and hospitalisation Improved exercise tolerance, quality of life, NYHA class Decreased mortality Decreased incidence of sudden cardiac death No proven benefit in chronic heart failure Potential problems Relatively high non-response rate Procedural complications (early and late) Uncertain quality-of-life benefits Inappropriate discharge Procedural complications (early and late) Worsening left ventricular function in systolic chronic heart failure in certain modalities Cost14 High: public hospitals, $21 075; private hospitals, $59 100* High: public hospitals, $14 975; private hospitals, $45 100† Relatively low NYHA = New York Heart Association. RA = right atrial. RV = right ventricular. LV = left ventricular. * Costs for cardiac resynchronisation therapy include: (public hospitals) generator, $17 000; RA lead, $475; RV lead, $1500; LV lead, $2100; and (private hospitals) generator, $44 500; RA lead, $1350; RV lead, $8750; LV lead, $4500. † Costs for implantable cardioverter defibrillator include: (public hospitals) generator, $13 000; RA lead, $475; RV lead, $1500; and (private hospitals) generator, $35 000; RA lead, $1350; RV lead, $8750.

Henry Krum MB BS, PhD, FRACP · Prashanthan Sanders MB BS(Hons), PhD

Objective: Design, setting and participants: A population-based study of 789 240 term singleton births in public and private hospitals in 2001–2004, using data from the National Perinatal Data Collection.Main outcome measures: Third- and fourth-degree perineal injury, requirement for high level of neonatal resuscitation, Apgar score < 7 at 5 minutes, admission to neonatal intensive care unit or special care nursery, and perinatal death.Results: 31.4% of the term singleton births occurred in private hospitals. After adjusting for maternal age, Indigenous status, parity, smoking status, diabetes, hypertension, remoteness of usual residence, and method of birth, the rates of all adverse outcomes studied were higher for public hospital births. For women, the adjusted odds ratio (AOR) for third- or fourth-degree perineal injury was 2.28 (95% CI, 2.16–2.40). For babies, the odds of a high level of resuscitation (AOR, 2.37; 95% CI, 2.17–2.59), low Apgar score (AOR, 1.75; 95% CI, 1.65–1.84), intensive care requirement (AOR, 1.48; 95% CI, 1.45–1.51) and perinatal death (AOR, 2.02; 95% CI, 1.78–2.29) were all higher in public hospitals.Conclusion: For women delivering a single baby at term in Australia, the prevalence of adverse perinatal outcomes is higher in public hospitals than in private hospitals.

Stephen J Robson MPH, MD, FRANZCOG · Paula Laws BAppPsych(Hons) · Elizabeth A Sullivan MB BS, MPH, MMed(Sexual Health)

Objective: To investigate sociodemographic variation in antidepressant utilisation.Design and setting: Cross-sectional analysis of antidepressant prescription under the Pharmaceutical Benefits Scheme in Australia, 2003–2005.Main outcome measures: Antidepressant utilisation (defined daily dose/1000/day) by sex, age, socioeconomic status (SES) and geographichal area.Results: Total antidepressant utilisation increased with age. Among those aged ≥ 15 years, female utilisation was about double that of males. About half of antidepressant utilisation was accounted for by sertraline, venlafaxine, citalopram, and paroxetine. SES differentials in antidepressant utilisation changed across age groups for males and females: among those aged ≤ 19 years, total antidepressant utilisation was significantly less in lower SES groups (P < 0.001); there was no relationship to SES among 20–29-year-olds; and among those aged ≥ 30 years, antidepressant utilisation was significantly higher in lower SES groups (P < 0.001). SES differences were attenuated after adjusting for urban or rural residence, but remained statistically significant. Antidepressant utilisation rates were highest in regional centres.Conclusion: Antidepressant utilisation in Australia partially reflects sociodemographic differences in the prevalence of affective disorder. Discrepancies between treatment provision and treatment need suggest that not all social strata in Australia have equal access to these treatments.

Andrew N Page BA(Psych)(Hons), PhD · Sarah Swannell BPsych(Hons), GradCertBiostat · Graham Martin MD, FRANZCP, DPM · Samantha Hollingworth BSc, MPH, PhD · Ian B Hickie MB BS, FRANZCP, MD · Wayne D Hall BSc, PhD

Objectives: To identify the incidence of self-reported harmful adverse events in the health care of community-dwelling adults, and to examine attitudes about safety in the health system.Design: Cross-sectional, population-based survey.Participants and setting: Analysis of data from 3522 adults participating in Stage 2 of the North West Adelaide Health Study, who were surveyed in 2004 and 2005.Main outcome measures: Self-reported adverse events causing harm in the past year; attitudes to safety in health care, including adequacy of current measures for preventing adverse events, and the effect of groups like patients themselves, doctors and governments on patient safety.Results: The annual incidence of self-reported harmful adverse events was 4.2%. The main types were medication error (45.5%) and misdiagnosis or wrong treatment (25.6%). Multiple logistic regression showed that self-reported harmful adverse events were more likely in people who had been hospitalised in the past 12 months (odds ratio [OR], 2.5; 95% CI, 1.9–3.4), those who had low annual income (< $12 000), those who completed higher education to the level of Bachelor degree or higher (OR, 3.0; 95% CI, 1.0–9.4), and those who had some level of dissatisfaction with their recent health care; and less likely in those more risk-averse rather than those with a tendency to risk-taking behaviour (OR, 0.6; 95% CI, 0.4–0.9). People were more likely to believe that individual health care professionals had a positive effect on safety than professional groups or government, and that more resources were the key to improving the safety of health care.Conclusion: We found an incidence of self-reported harmful adverse events that was significantly lower than that found by a 2002 Australian survey (4.2% v 6.5%; P = 0.009). Better communication to help patients acquire more realistic risk perception may help reduce harm. Better communication could also increase public advocacy for systems improvement in safety to counter persisting community beliefs that individual action alone can redress the situation.

Robert J Adams MD, FRACP · Graeme Tucker BSc · Kay Price RN, MA, PhD · Catherine L Hill MB BS, BS(Epid), FRACP · Sarah L Appleton BSc · David H Wilson BEd, MPH, PhD · Anne W Taylor MPH, PhD · Richard E Ruffin MB BS, MD, FRACP

Objective: To determine the rate of perinatal hepatitis B virus (HBV) transmission in an Australian setting and to identify maternal virological factors associated with highest risk of transmission.Design, participants and setting: A prospective, observational study of perinatal transmission of HBV. Participants were pregnant women attending Sydney South West Area Health Service antenatal clinics who tested positive for hepatitis B surface antigen (HBsAg), and their babies. All babies were routinely offered hepatitis B immunoglobulin (HBIG) and HBV vaccination. Babies positive for HBsAg at 9-month follow-up underwent further virological testing, including HBV DNA sequencing. The study was conducted between August 2002 and May 2008.Main outcome measures: HBV DNA levels and demographic characteristics of HBsAg-positive pregnant women; proportion of their infants with active HBV infection at 9-month follow-up; maternal characteristics affecting transmission rate; HBV DNA sequencing of infected infants and their mothers.Results: Of 313 HBsAg-positive pregnant women, 213 (68%) were HBV DNA-positive and 92 (29%) were positive for hepatitis B “e” antigen (HBeAg); 138 babies born to HBV DNA-positive mothers were tested for HBV infection (HBsAg positivity) at about 9 months of age. Four cases of transmission were identified. All four mothers had very high HBV DNA levels (> 108 copies/mL) and were HBeAg-positive. Three of the four infants were infected with wild-type HBV strains, with identical maternal/infant isolates. The fourth mother–infant pair had an S gene variant, HBV D144E, which has been previously reported in association with vaccine/HBIG escape. (Unfortunately, HBIG was inadvertently omitted from the immunisation schedule of this infant.) Transmission rates were 4/138 (3%) from HBV DNA-positive mothers overall, 4/61 (7%) from HBeAg-positive mothers, and 4/47 (9%) from mothers with very high HBV DNA levels. No transmission was seen in 91 babies of mothers with HBV DNA levels < 108 copies/mL.Conclusion: In this cohort, HBV perinatal transmission was restricted to HBeAg-positive mothers with very high viral loads.

Elke Wiseman MB BS, FRACP, PhD · Melissa A Fraser RN(Hons), GradDipInfectCont · Sally Holden · Anne Glass RN · Bronwynne L Kidson RN · Leon G Heron MB ChB, FRCPA, FAFPHM · Michael W Maley MB BS, FRCPA, FRACP · Anna Ayres BSc(Hons) · Stephen A Locarnini BSc(Hons), MB BS, PhD · Miriam T Levy MB BS, FRACP, PhD

Early detection of breast cancer has been shown to reduce breast cancer deaths in randomised controlled trials (RCTs) of mammography in women aged 50–69 years, with weaker evidence of benefit in those aged 40–49 or 70 years and older. Magnetic resonance imaging (MRI) and ultrasonography have been evaluated in breast cancer screening, relative to, or in addition to, mammography, in selected populations; neither test has been examined in an RCT, and thus evidence of associated screening benefit is uncertain. MRI is more sensitive than mammography in screening women with suspected or proven inherited mutations of the breast cancer genes. The addition of MRI in screening this population detects 8–24 additional cancers per 1000 screens, but also significantly increases a woman’s risk of being recalled for investigation or surgical biopsy for false-positive findings. In Australia, Medicare funding for MRI screening of women in specific risk groups was announced in February 2009. Ultrasonography can detect cancers not identified on mammography in asymptomatic women with dense breast tissue. Incremental ultrasound cancer detection is reported in 0.27%–0.46% of women with mammography-negative dense breasts; evidence varies on its association with false-positive findings. Computer-aided detection (CAD) is a complementary tool to mammography, prompting the reader to consider lesions on the mammogram that may represent cancer. Emerging evidence and improved CAD technology are likely to help define its role in breast screening.

Nehmat Houssami MB BS(Hons), FAFPHM, PhD · Sarah J Lord MB BS, MSc(Epi) · Stefano Ciatto MD, PhD

The aim of the National Health Priority Area (NHPA) initiative is to promote cooperation between government and non-government organisations to monitor, report on and develop strategies to improve health outcomes for Australians. The seven existing NHPAs (cancer control, injury prevention and control, cardiovascular health, mental health, diabetes mellitus, asthma and musculoskeletal conditions) were selected on the basis of their profound burden on the health of Australians. Up to eighty per cent of Australians will experience back pain at some point in their lives and 10% will experience significant disability as a result. Back pain disrupts individuals’ quality of life and accounts for an enormous cost to the community. Integrating back pain into the NHPA framework has many potential benefits, including more systematic development and implementation of programs aimed at minimising back pain-related disability by providing a focus for policy, legislation and public awareness; and promotion of best-practice management of the condition. A disadvantage of making back pain an NHPA is the risk that back pain management could become further medicalised and ineffective interventions could become more accepted. Coordinated action on back pain is needed, and integrating back pain into the NHPA framework is one solution. Informed decision making through consultation with key stakeholders is a necessary first step towards ensuring that favourable outcomes are achieved.

Andrew M Briggs BSc(PT)Hons, PhD · Rachelle Buchbinder MB BS(Hons), PhD, FRACP

Regina v Gillett deals with a man who did not disclose his epilepsy when seeking a drivers licence. Subsequently, he had a seizure while driving, causing an accident in which three people died. He was found guilty but appealed. During the trial to decide whether Gillett was guilty of dangerous driving occasioning death, the judge decided that the Austroads fitness-to-drive guidelines were extraneous to legal consideration of the acceptable risk to be attached to chronic medical conditions. Although the appeal was unsuccessful with respect to guilt and sentencing, it did reinstate the relevance of the Austroads guidelines when evaluating suitable risk with respect to potentially dangerous drivers. We suggest that even greater protection can be afforded to the community if a clearly enunciated warning, outlining a driver’s responsibilities, were to appear on each drivers license.

Roy G Beran MD, FRACP, FRACGP · Paul Gerber LLB, DJur · John A Devereux BA, LLB, DPhil

In June 2008, the ABC screened a television documentary involving a couple who decided to have an additional child in the hope of obtaining umbilical cord blood to treat their daughter who had leukaemia. The couple conceived naturally, meaning that there was a one in four chance that their child would be suitably matched. They seemed to be unaware of technologies that, if successful, could provide a near certainty that the next child would be a matched “saviour sibling”. This story raises questions about whether clinicians have an obligation to discuss emerging and morally contentious treatment options. Ignorance of technology, assumptions about availability, and medical assessment of burdens and benefits may affect attitudes towards treatment options, but they do not justify non-disclosure of information.

Kimberly A Strong BSc, GradDipGenCouns

For many thousands of years it has been recognised that disasters have significant physical and psychological effects on human society. Some of the earliest written records from Sumeria comment on the destruction of Nippur in 2000 bc and report on the anguish and suffering of the population.1 More recently, research has provided ample evidence of psychiatric morbidity in the wake of natural and human-caused disasters.2 Much of the research has focused on post-traumatic stress disorder (PTSD), but other conditions such as depression and anxiety disorder have also been reported. Initial high rates of distress usually diminish over the ensuing months, except for the people most intensely exposed to disaster stressors such as threat to life, loss of loved ones and loss of home. Earthquakes have been associated with enduring rates of PTSD as high as 25% in the affected population, highlighting the need for mental health interventions.3 Children are particularly vulnerable in such circumstances.4 These issues were again brought to prominence with the Sichuan earthquake that occurred on 12 May 2008: 69 000 people were left dead, 374 000 injured and 4.6 million homeless. Many Chinese psychiatrists, psychologists and volunteers gave up their normal duties to help the affected people, who were experiencing a high level of psychological morbidity. They faced overwhelming levels of distress in the affected population and were keen for further detailed information to carry out their roles more effectively. A strong partnership established over the past 4 years between Peking University Institute of Mental Health and Asia–Australia Mental Health provided the basis for developing a collaborative program to support China’s response to mental health problems in the immediate aftermath of the Sichuan earthquake. Asia–Australia Mental Health is a consortium of St Vincent’s Health and the University of Melbourne’s Department of Psychiatry and Asialink, of which two of us (C N and J F) are directors. This partnership had focused on models of community mental health care more broadly, and before the earthquake had already established guidelines for supporting children in disaster situations.5 These were disseminated to affected regions in China and across the country. Soon after the earthquake occurred, a group of experts with experience in the field of mental health in disasters and psychosocial response was formed in Australia to plan and develop an education program. The group consisted of core members of Australia’s national disaster mental health coordinating process, the National Mental Health Disaster Response Taskforce. They were invited to develop the program in partnership with senior members of the ongoing collaboration from China. The Australian training team dealt with concepts such as “psychological first aid” and personal support; planning, organisation and implementation strategies; resilience building; the needs of children and other vulnerable populations; evidence-based intervention strategies for trauma, grief and other stressors (such as dislocation, loss of home, and injuries); and multiple consequences linked to what was known about the impact of the disaster. The Australian training team developed resources and presentation material in Australia, which were sent to the Chinese organisers through the leader of the process in China, Professor Ma Hong, of the National Centre for Mental Health, China Center for Disease Control and Prevention/Peking University Institute of Mental Health. The material was translated, shaped to suit local need, and prepared for an education and training program that took place in Chengdu in Sichuan Province in early July, 2 months after the earthquake. Three of us (B R, an expert on mental health response to trauma; A C, a senior manager leading emergency management for the Australian Red Cross; and R M P, who played a significant role in mental health recovery of Australians affected by the second Bali bombing6) were invited to conduct the training in association with senior faculty members of the Peking University Institute of Mental Health, with representatives from the provinces and from volunteer organisations such as Hope China. The training program was funded by AusAID and supported at a very high level in the Chinese Government, with Bai Huan, Deputy Director-General of the Bureau of Diseases Prevention and Control and Yang Gonghuan, Executive Director of the China Center for Disease Control and Prevention attending the opening ceremony. In his speech, Yang Gonghuan emphasised that mental health is an essential component of disease control in China. Those attending the workshop had volunteered or been sent to provide assistance to the affected population, and most had been working intensively in the region from the earliest time after the earthquake. Apart from these workers, senior mental health professionals from every province in China attended the workshop, to make up a total of 280 participants. The stories of their experience movingly portrayed the huge extent of the disaster and the human distress engendered: families who had lost their only children; seriously injured children being cared for in hospital; and the multitudes who had lost their homes, their way of living, their communities, and their capacity to work. At the same time, there were many stories reflecting the enormous courage and resilience of the people affected, and the compassion and dedication of those who had dropped everything to help them. Workers themselves were stressed by the extent of suffering they had witnessed. There were also stories of the ongoing aftershocks, re-awakening the trauma experience and adding to the difficulties of managing the consequences. Many Chinese speakers as well as visitors contributed to the presentation at the workshop, reinforcing the value of the partnership approach. Before the workshop, the Australian delegation was involved in preparatory work with teams of translators in the delivery of the lectures. This was a delicate and difficult task, with each line of text from 200 or more slides having to be worked through by the presenters and their allocated translator. The workshop was jointly conducted over 4 days and consisted of lectures with simultaneous English and Chinese PowerPoint (Microsoft Corporation, Redmond, Wash, USA) presentations on a range of topics. The lectures were conducted in a spirit of equal partnership with Chinese faculty members, with shared responsibility for material (Box). It became quickly apparent to the training team that participants wanted more engagement with the training process than could be simply developed through a “lecture program”. As a result, the Australian training team developed role plays around specific aspects of psychological first aid as well as responding to participants’ “questions from the floor”. In the evening, the Chinese faculty members provided supervision to the groups of volunteers and mental health professionals, helping them deal with their own emotional issues relating to working with the affected people. The effect of the earthquake on ordinary Chinese people was apparent in conversations such as those with the people of Pengzhou, a town destroyed by the earthquake, during a visit by the Australian team to the reconstruction village there. One of our team (C N) summed up the thoughts of the Australian delegation when he stated: The devastation of the earthquake that shook this province on 12 May will always be remembered. But the horror also brought a rare opportunity for all of us to rethink what really matters, to reach out to other humans who are suffering. People across China have responded with “one heart”. And people overseas, as far [away] as Australia, are moved to make a contribution. The workshop concluded with a banquet, providing a wonderful, warm and joyous opportunity for the visitors to share their experiences and express their respect for and recognition of the achievements of their Chinese colleagues in responding to this catastrophe. The ongoing effect of the training from the workshop was also evidenced by the further work done after the earthquake by Professor Xin Fang, a Chinese faculty member. Professor Xin, who has specific training in the psychotherapy of trauma, had given up her regular work to volunteer to help people affected by the earthquake. After participation in the workshop, she was travelling to Mongolia and Guangzhou to pass on the information she had learned to senior education officials and police, to help their organisations cope better with the psychological consequences of trauma. Asia–Australia Mental Health and the Peking University Institute of Mental Health agreed to build on the success of the workshop by conducting further training, including consolidating the training of the participants in the initial workshop. Both groups have looked to the development of further research to evaluate the effect of the training as well as mentoring of senior Chinese academics and policymakers to continue the progress of the initiative. Concluding comments at the workshop expressed the view that this model of partnership had been invaluable. It brought the strengths of mutual respect, and a recognition of the importance of continuing to develop new understanding that would be helpful, not only to China and Australia, but also for many other countries facing such disasters in the future. The education program A systemic approach of psychosocial response to disasters* Assessment of physical injury and first aid† Team leadership* Disaster worker recruitment* Maintaining a functioning team* Information and communication* Psychological first aid* Personal support* Clinical programs and early intervention* Assessment and treatment of clinical disorders* Medication* Children and adolescent mental health issues* General population mental health issues* Medical ethics† Supporting people affected by the earthquake* Rebuilding communities* Assisting cultural minority groups† Multidisciplinary cooperation† * Australia. † China.

Robert M Parker BMed, AFACHSE, FRANZP · Chee Ng MMed, FRANZCP, MD · Andrew Coghlan BA(SocSc) · Julia Fraser BEd, DipEdAdmin · Beverley Raphael MD, DPM, FRANZCP

Twenty-five patients living in a tick-endemic region of Sydney, New South Wales developed red meat allergy after experiencing large local reactions to tick bites. This represents a potentially novel cross-reaction between an arthropod and a food protein. Clinical recordsBetween 2003 and 2007, 25 patients (seven men, 18 women; mean age [range], 29.9 [21–63] years) presented to our allergy practice in Sydney, New South Wales with a history of an allergic reaction to red meat. All 25 patients reported a clinical reaction (one or more of: urticaria, angioedema, respiratory distress, syncope) after ingesting red meat. Ten of the 25 patients (40%) reported a delayed onset of symptoms, as defined by manifestations occurring more than 4 hours after ingestion. Seventeen of the 25 patients (68%) had severe reactions, characterised by cardiorespiratory involvement (one or more of: tongue swelling, throat constriction, shortness of breath, wheeze). Beef was the most commonly implicated red meat, followed by lamb, pork and game; 11 individuals reported reactions to more than one type of red meat. All patients lived in the northern beaches region of Sydney, which is endemically infested with several tick species. Twenty-four of the 25 patients gave a history of large local reactions to tick bites, defined as the rapid or delayed onset of a painful, pruritic lesion greater than 50 mm in diameter that persisted for at least 1 week.1 They all stated that the organism responsible for their local reaction was a hard-bodied tick, based on the presence of an armoured shell (scutulum). They also provided an estimate of the tick’s size, which ranged from 3 to 10 mm, and recalled the shape as resembling that of a human fingernail. No patient reported a history of large local or generalised reactions to other bites or stings, such as those from honeybees, wasps or mosquitoes. The remaining patient did not report any reactions, despite having incurred multiple tick bites. In all but one case, tick exposure preceded the development of the meat allergy by 1 to 6 months. One patient’s onset of meat allergy preceded the tick bite by 6 months. Patients’ IgE-mediated responses to red meat were confirmed by skin-prick test and/or fluoroenzyme immunoassay (ImmunoCAP, Phadia, Uppsala, Sweden). All patients had a positive result for at least one type of red meat; 22/25 (88%) had a positive reaction to more than one type (Box 1). There was no correlation between the wheal size on skin-prick testing or the amount of specific IgE detected by fluoroenzyme immunoassay and either the severity of the response to red meat ingestion or the size of the local reaction to the tick bite. The records of 29 patients (10 men, 19 women; mean age [range], 34.1 [17–71] years) with confirmed IgE-mediated responses to foods other than red meat, attending the same practice and residing in the same region, were examined as a retrospective control. The control group comprised patients with reactions to a spectrum of foods, most commonly seafood, peanut, tree nut and soybean. All 29 patients had reported a history of tick bites without subsequent reaction. These findings suggest that, in our patient population, the overwhelming majority of cases of the relatively rare condition of red meat allergy were preceded by sensitisation to tick bites. DiscussionBased on our experience of 25 patients, we suggest a novel association between tick bite reactions and red meat allergy. We speculate that individuals are sensitised to tick salivary proteins that are cross-reactive with proteins found in various red meats. Cross-reactivity between milk and beef,2 and between animal epithelia and meat,3,4 has been previously described, suggesting mechanisms of secondary sensitisation to meat. The association with reactions to tick salivary proteins may represent another such example. Anaphylactic and large local reactions to tick bites are IgE-mediated responses to tick salivary proteins.1 We infer that the species of hard-bodied tick most likely to be responsible for these local reactions is Ixodes holocyclus, commonly known as the paralysis tick (Box 2). I. holocyclus is not only the major species of tick found in the northern beaches region of Sydney that affects humans, but is also the species responsible for hypersensitivity reactions in humans.5 However, a skin-prick solution comprising paralysis tick antigens has not been standardised, and an in-house preparation carries a risk not only of anaphylaxis, but also of introduction of tick-borne disease; hence, there is currently no reliable, safe method of detecting IgE antibodies against I. holocyclus. It is intriguing that none of our patients who developed red meat allergy had an anaphylactic reaction to tick bite. It is possible that different allergens are involved in IgE-mediated local reactions and anaphylaxis, and that the allergens involved in local reactions are also found in red meat proteins, or, alternatively, that the inoculated allergens are processed differently in different individuals. There may be poorer inactivation of allergens by mast cells at the local site in some individuals, resulting in a more prolonged immunological stimulus.6 Bovine serum albumin has been identified as a major allergen responsible for a number of cases of meat allergy.7 More recently, IgE antibody to galactose-α-1,3-galactose has been identified as a cause of anaphylaxis and delayed immune reactions to red meat.8 This molecule is also present in recombinant mouse-derived monoclonal antibodies, such as cetuximab, and a number of invertebrates, such as amoebae and worms.9 It remains to be determined whether such homologous allergens exist in tick saliva. An alternative explanation is simply that the transfer of animal allergens by the tick occurs in genetically predisposed individuals. Bandicoots, possums and dogs, rather than cattle, are recipients of bites from the I. holocyclus species of tick, and it is therefore possible that there are allergens with a high level of homology found within bandicoot, possum and various ingestible red meat proteins. Also, the possibility of cutaneous exposure as a route of sensitisation to food allergens has been postulated as a mechanism for the development of peanut allergy.10 To determine the true prevalence of this cross-reactivity, a prospective study could examine consecutive patients who are bitten by ticks (with and without adverse reactions) for the subsequent development of red meat allergy. A standardised in-vitro assay for specific IgE against tick salivary allergens would need to be developed and incorporated into each participant’s evaluation. Further studies are required to characterise these allergens with immunoblotting and inhibition studies. 1 Skin-prick test and fluoroenzyme immunoassay results for patients with clinical reactions to red meat Patient Skin-prick test Fluoroenzyme immunoassay Beef Pork Lamb Game* Beef Pork Mutton 1 + − + nd + + − 2 + nd nd nd nd nd nd 3 nd nd nd nd + + + 4 + − + nd + + + 5 + nd nd nd nd nd nd 6 + + nd + nd nd nd 7 nd + nd nd nd nd nd 8 nd nd + nd + nd + 9 + + + + nd nd nd 10 + + + nd nd nd nd 11 + + + nd nd nd nd 12 + + + nd nd nd nd 13 + + + nd nd nd nd 14 nd nd nd nd + + + 15 + + + + + + + 16 + − + nd nd nd nd 17 + + nd + nd nd nd 18 nd nd nd nd + + nd 19 + + + nd − − − 20 + − + nd − − − 21 + + + nd nd nd nd 22 + nd + nd nd nd nd 23 + + + nd − nd − 24 + − + nd nd nd nd 25 nd + nd + + + + * Game refers to meat from wild animals, including kangaroo, venison and rabbit. + = positive result. − = negative result. nd = not done. 2 Developmental stages of Ixodes holocyclus Left to right: larva; nymph during engorgement; and adult female during engorgment. Image courtesy of Dr Bernard Hudson

Sheryl A Van Nunen MB BS, FRACP · Kate S O’Connor MB BS · Lesley R Clarke BSc, GradCertDiet · Richard X Boyle MB BS, FRACGP · Suran L Fernando PhD, FRACP, FRCPA

To the Editor: Although the Garling report1 is the latest (and longest, at 1195 pages) in a long line of reports on the state of public hospitals to be commissioned by state and territory governments, the three articles in the Journal commenting on this report are timely and have brought out the fundamental problems with public hospitals Australia-wide, not just in New South Wales.2-4 These problems were highlighted by Van Der Weyden in pointing out the “pervasive sense of loss — loss of control, loss of direction, and loss of ownership by the hospitals’ serving health professionals, politicians, and the community”;2 by Skinner and colleagues commenting on “the progressive centralisation . . . and disempowerment of both clinicians and the community” and the failure of this approach;3 and by Stewart and Dwyer with their comments on resourcing, and the seriousness of the divide between clinicians and managers.4 These remarks in particular are entirely consistent with my own observations from my work in a number of hospitals throughout Australia in the course of doing consultancies or accreditation surveys in recent years. It is now time to stop “resort[ing] to conducting inquiries”2 and for the federal and state governments to work cooperatively to implement the three main solutions that clearly emerge from the issues raised by Garling and the MJA commentators, which are: appropriately resourcing public hospitals, including opening and staffing sufficient numbers of additional beds (to replace the many shut by economic rationalists); re-establishing community boards for individual hospitals or small related groups of hospitals in those states in which they have been abolished. These boards must have members chosen for their skills and experience, not their politics, and be accountable to the communities they serve; and reversing the alienation of clinicians by engaging them in all levels of governance, not only by consulting them but by ensuring that they are actively involved and part of the whole decision-making process. Offering Executive Clinical Director posts1 is necessary but not sufficient to achieve these aims, and must not amount to tokenism. Despite the huge number of recommendations in Garling’s and other reports, addressing these three matters would go a long way toward fixing the problems in public hospitals across jurisdictions. This would help to restore the faith of doctors in the public hospital system, help give communities and clinicians a sense of ownership and pride in their hospitals, and boost morale, so that hospitals can once again become centres of excellence in a re-energised health system.

Michael (Taffy) R Jones

To the Editor: It is easy to contemplate redesigning the medical wheel in the face of grossly dysfunctional health services. Garling’s scholarly report1 is unlikely to be adopted to any significant extent by a government that has already sent negative signals. Menadue’s suggestions for new and reassigned responsibilities2 are counsels of perfection for systems that are not capable of making radical changes. Indeed, as illustrated by Van Der Weyden,3 there is a general perception that all informed action has been replaced by ignorance, inertia and an appalling loss of morale. A superficial scan of the Internet reveals some remarkable information. In December 2008, the federal government approved the distribution of $580 million to 11 universities for various education-investment projects in science, research and health.4 The University of Adelaide Library lists more than 70 public health organisations in Australia.5 The Australian Health Economics Society advertises 33 sources of teaching and research available from local and international teams of 35 to 60 experts.6 These represent only a small sample of many similar sites. Clearly, there are a vast number of enterprises in Australia that are considered — by themselves or reputable others — to be capable of advising on research and development. Of course, their credentials cannot be taken for granted, but a majority seem to be supported by distinguished institutions and personnel with expertise in health management, economics, research and policy. Despite this, we keep seeking new minds, commissions and inquiries to reshape what has long since become a square wheel. I suspect that we might already have much more expertise than we need or could ever use. The cast-aside opinions of long-established groups should be disinterred and urgently re-examined before directing new funds and more time to destructively unproductive and ill-informed bureaucracies. It may be that crucial medical decisions should only be made by those who at some time have worked — and wept — in busy emergency or intensive care wards late at night. Equally, the remarkable organisation and expertise of military hospitals in Iraq and Afghanistan clearly show that miracles can be accomplished when a mix of workers, will and wisdom7 is applied to supreme demands. Can we not learn from that?

John S Wright

To the Editor: The Garling report highlights gaps in the New South Wales health system and establishes a framework for change.1 We support Garling’s view that there is a need for greater measurement of the health system to assess quality of care, and we believe that clinical networks have an important role to play in establishing, interpreting and actioning quality indicator data.2 But the statement that “There is already a great reservoir of information available within NSW Health from which data are available to measure the quality of patient care ...”1 is unhelpful in moving this work forward. While it is true that vast amounts of data are collected and classified using the ICD (International classification of diseases) coding system, in their current state these data have limited ability to accurately measure quality and drive change at a clinical level, for a number of reasons. First, data are not recorded in the medical record in a planned and systematic manner using agreed definitions, making findings susceptible to reporting bias. Second, the coding system fails to accurately account for differences in patient casemix, which is needed to enable appropriate risk adjustment to occur. This was recently highlighted in the United Kingdom when administrative data were compared with registry data to assess outcomes after cardiac surgery: admitted episode data underestimated the number of patients receiving treatment by approximately 20%, and captured only between 27% and 78% of deaths at 30 days in nine of the 11 centres undertaking cardiac surgery.3 Others have gone down the path of investing huge sums of money to measure quality using administrative data and reward high performers, with moderate success at best.4 To emulate this approach in the absence of further investigation would be premature. To measure quality of care we need to: invest in developing high-quality clinical registries across a broad range of high-cost, high-impact diseases and procedures. Where these have been introduced, they have had demonstrable impact on improving patient outcomes.5 These registries may be populated in part by data elements from existing data sources, where these are of high quality. develop data fields for the electronic medical record to ensure that data are epidemiologically sound. This work must include the adoption of unique identifiers to enable monitoring of treatment across care boundaries. validate and test proposed indicators, which might be collected from existing data sources. It is only through assuring clinicians that the data used to measure quality of care are reliable and clinically relevant that they will have any positive impact on changing practice.

Sue M Evans · Peter A Cameron · John J McNeil

To the Editor: The Garling report,1 reviewed by Van Der Weyden2 and others in the Journal, yet again brings to our attention the problem of bullying within our health care system. New South Wales is not alone in having this problem, as it has been highlighted across many systems throughout Australia and the rest of the world over the past 10 years.3 Garling acknowledges that the current guidelines in NSW are robust and comprehensive, but that there are serious deficiencies in their implementation. His report then goes on to suggest implementing the “Just Culture” program within the NSW health system.1 I would hold that if the policies and procedures already laid down are adequate, there is little point in reinventing the wheel and expending a large amount of time and energy, not to mention fiscal resources, in developing new guidelines, which, in all probability, will not be followed either. To minimise bullying in the workplace, one must be aware of the root causes of the problem — these include improperly trained managers, financial pressures, and a resultant “survival” culture within stressed environments. Many Australian public hospitals operate in a resources-limited, highly pressurised environment, where the culture is often adversarial — as pressure on the system grows, so does bullying. Garling correctly suggests that there must be zero tolerance for bullying behaviour within the workforce. This, however, needs to be more than just window dressing and must be rigorously enforced throughout the organisation, from the top down. Positive reinforcement of good interpersonal relationships, rather than the constant negative feedback that health care workers have come to expect, will reap rewards and aid the cultural change required. Training of people in management roles is essential, and all staff within the organisation must be aware of the expectation that they will work together in a collaborative and respectful relationship for the benefit of the patient. In the final analysis, in workplaces where a culture of openness and respect is present, bullying is likely to be minimised. In public hospitals in NSW and in most other Australian states where bullying is an ongoing problem within the workplace, the solution is not to institute yet another program to combat the issue, but to properly implement the policies and procedures that are already in place, and to develop an open, non-adversarial environment in which excellence in health care can flourish.

Alan E O’Connor

To the Editor: Three articles in a recent issue of the Journal1-3 call for implementing the changes recommended in the Garling report.4 One recommendation is that the appalling practice of placing male and female patients in the same room in general wards, and sometimes in adjoining beds, “must stop immediately”.4 This practice, and the sharing of toilets and showers associated with it, exemplifies a disregard for the human dignity of patients and lack of respect for the principles underpinning consent at the level of hospital and ward management. Trialled in the United Kingdom for reasons of economy and later banned on the grounds of patient welfare,5 the practice is not evidence-based and has been objected to in New South Wales through letters to the Minister for Health, in occasional newspaper articles, and through patient complaints to the NSW health consumer watchdog body. The responses to date point to the practice being considered acceptable by the powers that be on the basis of alleged efficient use of beds and the claim that “a hospital will make every attempt to relocate those who object”.6 Van Der Weyden,1 Stewart and Dwyer,2 and Skinner and colleagues3 cite prioritisation of recommendations, provision of funding, strong leadership, continuing consultation with clinicians and the community, and partnerships between state and federal governments as important ingredients for implementing the recommendations of the Garling report. Implementing the recommendation on mixing the sexes requires no more than an administrative edict to the effect that this practice is no longer permissible. The period of time it takes to issue this edict will be a good index of how serious we are about getting on with fixing what’s wrong in NSW hospitals.

Judith R Kennedy · Michael C Kennedy

To the Editor: At school we were counselled that the most important criterion for passing examinations was to answer the actual questions asked and to avoid adding irrelevant material. The Garling report considered the organisation of New South Wales public hospitals, concluding: If public hospitals are to survive as providers of free care for all, there will have to be some radical changes in the way they do business.1 Stewart and Dwyer’s commentary on Garling’s proposals2 ignores this core theme. Garling recommends many significant changes that would directly affect doctors,1 such as: Within 6 months, NSW Health should redesign rostering systems and practices to ensure an appropriate number of senior clinicians are in hospitals for 16 hours a day, 7 days a week. NSW should require that all ward rounds occur in the early morning, be multidisciplinary, and that accurate and complete notes are taken and approved by the supervising doctor within 24 hours. Rather than discussing the consequences, implications and implementation of Garling’s recommendations, Stewart and Dwyer air opinions on federal–state financial relationships, arguing that: It is time for the Rudd Government to live up to its pre-election rhetoric and work with the states in urgently restoring adequate funding to the public hospital system.2 Stewart and Dwyer’s confused intent is evident in their criticism of federal funding provided to NSW in 2008 “to help divert patients who are not thought to need urgent care away from emergency departments and towards general practice services”. They believe this money “would do much more for emergency departments if it were used to open more beds and reduce access block”. However, later in their article they declare that “looking at a huge hospital system in isolation from other parts of the health care system is a somewhat artificial exercise”.2 Stewart and Dwyer’s views on the practical feasibility and day-to-day implications for doctors of Garling’s proposals would have been of interest. Broader health financing issues, including respective federal and state responsibilities, were not the focus of Garling’s report. In reply: Coote is correct that the true benefits of the Garling recommendations lie in the details of implementation. This was not, however, our brief in our article;1 we were asked to identify the root causes of the current crisis in New South Wales public hospitals and to assess against these the potential for the Garling recommendations2 to pull the system “back from the brink”. From our list of 16 causes, we chose to give particular attention to the federal–state divide and the increasing disengagement of clinicians. The reduction in federal funding to public hospitals over the past decade has been a major driver of clinician dissatisfaction and the widening gap between frontline workers and management, as is well captured in the Garling report.2 Reduced resources, including insufficient hospital beds, have driven the centralisation of authority and underpinned the bullying behaviour of some managers. A sizeable proportion of the much needed reforms recommended by Garling will be difficult to implement without the Australian Government providing its fair share of funding for the public hospital system. In this context, a detailed implementation plan for Garling’s recommendations is essential — but, unfortunately, the recently released response from the NSW Government3 is very weak in this regard. Clinicians appear to have a long, hard struggle ahead to ensure that the road map to recovery laid down by Garling is followed by government and the bureaucracy, and that the changes needed are funded adequately.

William Coote · Graeme J Stewart · John M Dwyer

To the Editor: We are concerned that conclusions drawn by Robson and colleagues1 regarding perinatal outcomes in private and public hospital settings perpetuate misinformation about safe birthing options. One of the major limitations of using routine datasets, which the authors acknowledge, is that analyses are only able to control for potential confounders held within those datasets.2 Because these datasets are not designed for research, they commonly do not contain information on all pertinent indicators. In this case, the inability to control for expected and potential pregnancy complications affecting poor perinatal outcomes means caution is warranted when drawing conclusions about the safety of public versus private intrapartum care. The public hospital system in Australia is designed to cater for women at risk of adverse events in pregnancy and labour, regardless of their health insurance status. Women with known risk factors may opt for public care in a tertiary hospital, where neonatal intensive care facilities are available. Accounting for only a few surrogate markers of social disadvantage is unlikely to control adequately for inequities in these two very different populations. As such, the extent to which the reported odds ratios are a result of differences in the type of care provided in public and private hospitals, or underlying differences in the populations that have not been adjusted for, is unknown. By attending to odds ratios only, Robson and colleagues have missed the opportunity to disseminate information about overall risk across both health sectors. Although statistical models used in their study indicate the risk of perinatal death is three times more likely in public than private hospitals (taking account of caveats already discussed), the population risk of such adverse perinatal outcomes is extremely small regardless of place of birth. When using data from secondary sources, the onus is on researchers to exercise caution in interpretation and dissemination of results, because we know the media won’t. “Babies die in public hospitals ...”3 is just one example of how the general public are fed conclusions based on insubstantial evidence. We cannot foresee any benefit in undermining trust in our public hospital system. There is, however, potential for harm if women perceive they are in a substandard system of care. It is a simplistic assertion by Robson and colleagues that women can use the information presented in their article to make choices about giving birth in either the public or private sector. For many women, there is no choice.

Georgina A Sutherland · Deirdre Gartland · Jane S Yelland · Stephanie J Brown

To the Editor: In their recent article, Robson and colleagues conclude that women are at increased risk of adverse perinatal outcomes if they give birth in public rather than private hospitals.1 We are concerned that this interpretation is likely to be false, has caused the public unnecessary alarm, and may be used to support vested interests. There are several serious limitations in the data, the analyses and the implications. The authors report that 14.3% of women (about 134 000) giving birth in Australia during the study period were excluded from the analyses. We believe that this exclusion introduces significant bias. Outcomes and sensitivity analyses should have been presented for the excluded groups, enabling the reader to interpret the findings appropriately. Pre- and post-term births and multiple births were appropriately excluded from the analysis. However, perinatal deaths due to congenital anomalies should also have been excluded. In Victoria in 2004, 19% of perinatal deaths at term were caused by congenital anomalies.2 These almost always occur in public hospitals. The authors adjusted for a number of maternal demographic characteristics in their risk assessment. Other factors known to reflect sociodemographic status, such as education, occupation and income, and low birthweight, were not included; therefore the adjustment is unlikely to be adequate. The analysis should have been stratified by hospital level of care. Women at high risk of adverse outcomes should be (and are being) cared for in tertiary public hospitals — which, unlike private hospitals, are designed to provide high-level care — as a matter of need and not of choice. The lumping together of all public hospitals in the analysis and provision of summary outcomes necessarily skews the findings. By doing this, the authors are effectively comparing apples with oranges. The proper analysis of severe perineal laceration would exclude those women who had caesarean sections, because they are not at risk of perineal trauma. Stratification by type of vaginal birth is misleading when women attempting vaginal birth in private hospitals are much more likely to experience instrumental birth than those in public hospitals. In conclusion, differential exclusion of a significant proportion of the population, inadequate adjustment for confounding factors, lack of stratification by hospital type, and inappropriate analysis of perineal lacerations are likely to lead to faulty inference and cause unnecessary alarm. This is particularly unfortunate at the time of publication of the national Maternity Services Review.3

Lyndsey F Watson · Mary-Ann Davey · Mary A Biro · James F King

In reply: We thank Sutherland and colleagues for their comments and acknowledge that dissemination of our research findings1 by some in the Australian media has caused unnecessary alarm.2,3 The data presented in our article show that there appear to be different risk profiles for women giving birth in the public and private sectors in Australia. We agree with Sutherland et al that the “public hospital system in Australia is designed to cater for women at risk of adverse events in pregnancy and labour, regardless of their health insurance status” and/or risk profile. Watson and colleagues estimate that about 19% of all perinatal deaths among term births in Victoria are due to congenital anomalies.4 This is consistent with a reported national figure of 18.1% for 2004.5 This limitation should have been acknowledged in our article, even if the analysis was not possible. Congenital anomaly data are not currently included in the Perinatal National Minimum Data Set. This limitation highlights the need for integrated uniform national perinatal data on cause of perinatal death and diagnosis of congenital anomaly.

Stephen J Robson · Paula Laws · Elizabeth A Sullivan

To the Editor: We believe the current indications for subsidised treatment of osteoporosis specified in the Pharmaceutical Benefits Schedule (PBS) encourage over-prescribing on the one hand, yet, on the other, deny many patients with osteoporosis the treatment they need. For patients under 70 years of age, the PBS indication for specific treatment, such as bisphosphonate therapy, is “established osteoporosis with minimal trauma fracture”. Thus, perhaps surprisingly, treatment is indicated for secondary prevention only. More remarkable is that patients do not need to have osteoporosis to receive the benefit: repeated enquiries to Medicare (the most recent on 3 March 2009) have confirmed that prior measurement of bone mineral density (BMD), the only practical way to diagnose osteoporosis, is not required. Yet it is well known that only 20% of women with peripheral fractures from non-major trauma actually have osteoporosis, whatever BMD T-score is used diagnostically.1 Accordingly, the current policy simultaneously denies specific treatment to patients with osteoporosis who have not yet sustained a fracture while subsidising treatment to patients with fractures who are unlikely to have osteoporosis. There is little gain from bisphosphonate therapy in women who have normal BMD and no vertebral fracture,2 but good evidence that such therapy is effective if BMD is low.3 To remedy these anomalies, we believe that bone densitometry should be more readily available — not deferred until people have fractures or reach the age of 70 years. We support a bone density measurement for all women at the menopause (and perhaps all men at age 60 years). This would identify those with osteoporosis at high risk of fracture as well as those in the low-normal range who are at high risk of developing osteoporosis.4 The first group could be offered specific therapy to prevent fractures and the second group could be advised on preventive lifestyle measures such as calcium and vitamin D supplementation and appropriate exercise. We estimate that the cost, even if there was full acceptance, would be only about $20 million a year compared with the current $8 billion yearly cost of osteoporotic fractures.5 Our recommended policy revision could pay for itself many times over, even if there were only a 10% reduction in fracture rate, not to mention improvements to be gained in the quality of patients’ lives. Early recognition of low bone density and early diagnosis of osteoporosis has the long-term potential to transform the current depressing osteoporosis picture. We do not discount the importance of minimal trauma fracture, but believe that more weight should be given to vertebral fractures and less to peripheral fractures, as the former are much more likely to be osteoporotic, much more liable to recur,6,7 and much more responsive to specific therapies.3

B E Christopher Nordin · Michael Horowitz · Barry E Chatterton

Suicide prevention. Robert D Goldney. New York: Oxford University Press, 2008 (xi +105 pp). ISBN 978 0 19 953325 1. It is only in the past 15 years that suicide has been acknowledged as a potentially preventable public health concern, requiring broad national policies. Of course, much has been known about suicide for centuries, and this historical context is well described in Suicide prevention, Robert Goldney’s concise, well written overview. Professor of Psychiatry at the University of Adelaide, and an internationally acclaimed suicidologist and past president of the International Association for Suicide Prevention, his inexpensive pocketbook is very topical, given the current climate of global economic downturn. Despite the brevity of the text, Goldney clearly outlines the major issues relevant to suicide prevention from policy to practice. Perhaps the chapters on individual and clinical factors are stronger than those related to broader society and policy, a reflection, possibly, of Goldney’s clinical academic background, but it is a minor point. The clinical chapters provide the clinician with lucid, broad guidelines to aid assessment and management of the suicidal patient without being at all prescriptive. The recognition that the suicidal patient can be a challenge for many clinicians is crucial and timely. Pharmacological and non-pharmacological strategies are adequately covered. Key messages are helpfully summarised at the beginning of each chapter, and throughout there are boxes and tables outlining important issues. While there are references for each chapter, these seem to be more of a bibliography without any attempt to identify those that are more important. A brief list of useful website links is also provided. Although there are many books about suicide on the market, Suicide prevention fills a niche for students of various health disciplines, policymakers, and clinicians, by virtue of the relatively comprehensive yet succinct coverage of the topic.

Brian M Draper

Phil Douglas will be particularly remembered for his outstanding role in expanding the development of the Post Fellowship Training Programme of the Colorectal Surgical Society of Australia and New Zealand (CSSANZ) and the Royal Australasian College of Surgeons, nurturing it as a legacy to future fellows-in-training. The Society has recently established the annual Philip Douglas Prize in his honour. Phil was born on 30 November 1955 in Sydney. He attended Sydney Church of England Grammar School (“Shore”), where he was a prefect, a cadet under-officer, and member of the First XV rugby and Second XI cricket teams. Sport remained an important part of Phil’s life. After completing a medical degree at the University of New South Wales, Phil spent an additional year working towards a Bachelor of Medical Science degree. The project, for which he was awarded first class honours, involved research into the sensory pathways of the brain and was published in the prestigious Journal of Physiology. Phil was one of the first two fellows admitted under the auspices of the (then) Australian Colorectal Surgical (specialist) Training Programme. In 1990, after 2 years’ training at the Prince of Wales Hospital, Randwick, and the Adventist Hospital, Wahroonga, he became a consultant at the Prince of Wales Hospital. Phil was actively involved in many areas other than colorectal surgery. He was a councillor of the NSW branch of the Australian Medical Association (AMA) (1987–1993) and a director and board member of the AMA Health Fund (later The Doctors’ Health Fund) for 19 years. He also served on committees of the Gastroenterological Society of Australia and the Sydney Colorectal Surgical Society. He was chairman of the Medical Staff Council of the Prince of Wales hospitals (1999–2008) and ultimately chairman of the Medical Staff Executive Council of all hospitals of the South Eastern Sydney Area Health Service. In November 2008, Phil completed a most distinguished 2 years as President of the CSSANZ. A year earlier, metastases from a completely asymptomatic pharyngeal squamous cell carcinoma had been identified, resulting in a program of irradiation and chemotherapy, during which Phil stoically maintained an active clinical and surgical practice until his retirement just 2 weeks before his death, on 3 January 2009. Phil was determined, strong, rational and, above all, fair. He enjoyed many lifelong friendships and possessed a prodigious wine knowledge and tasting ability, which he lost after his radiotherapy — but, to his great joy, later regained. He is survived by his wife Judy and children Katherine and Cameron. His strong Christian faith was a dominant focus throughout his life. Phil is a direct descendent of Richard Rouse of Rouse Hill.

Graham L Newstead

An 81-year-old man presented with a 1-day history of right iliac fossa pain that radiated to the left iliac fossa. Vital signs were normal. Examination revealed abdominal distension with peritonism. An abdominal x-ray showed small bowel obstruction, and a computed tomography scan suggested a small bowel volvulus. Laparotomy revealed a small bowel obstruction due to a pendulous appendix (20 cm in length) that had wrapped around a loop of bowel, causing obstruction and ischaemia (Figure). Histopathological examination confirmed the presence of acute appendicitis with ischaemic small bowel. The patient recovered uneventfully. The average length of the adult appendix is 7.5 cm in men and 6.7 cm in women (SD, 2.1 cm; range, 2–26 cm).1 Small bowel obstruction secondary to “appendiceal tourniquet” is extremely rare, with only 12 cases previously reported.2,3

Richard H Riley · Richard J Martin

Older dads Offspring of older fathers appear to be more likely to have impaired neurocognitive outcomes in early childhood, according to results of a large US study. Using a sample of over 33 000 child participants from the US Collaborative Perinatal Project, researchers assessed the relationship between paternal or maternal age and outcome measures at 8 months, 4 years and 7 years. A range of neurocognitive tests was used and the data were analysed using two models, one taking into account the parents’ ages, and the other included the parents’ level of education and income. Advanced paternal age was significantly associated with lower scores on all but one of the neurocognitive measures. Near-linear decline with increasing paternal age was noted in most of the measures, and the association was independent of social factors. The authors comment that whether the children of older fathers “catch up” during later childhood is unknown, and that the mechanism of action may be related to genetic mutations in the male germ cell line or epigenetic mechanisms. PLoS Med 2009; 6: e40 Larvae for leg ulcers Larval therapy has become popular for the treatment of leg ulcers, based on the premise that their use stimulates healing, reduces bacterial load, and eradicates methicillin-resistant Staphylococcus aureus (MRSA). To formally test these hypotheses, researchers conducted a randomised controlled trial involving 267 patients with sloughy or necrotic leg ulcers. They set out to compare the effectiveness of larval therapy using either loose or bagged larvae with hydrogel — a standard ulcer dressing used for debridement. Although larval therapy resulted in more pain, did not increase healing rates or reduce bacterial load when compared with hydrogel, it significantly reduced the time to debridement of necrotic ulcers. The authors comment that there is much to learn about the role of debridement in ulcer healing. BMJ 2009; 338: b773 I’m going home . . . Why patients leave hospital against medical advice (AMA) is a difficult question, and one that researchers have attempted to answer in a US-based review, along with an analysis of predictors of such discharges and potential associated health care costs. Predictors of AMA discharge included younger age, lack of medical insurance, and a history of substance or alcohol misuse. Some studies had novel findings, including one that found that patients without a primary care doctor were more likely to discharge themselves AMA. The authors comment that the literature is limited to medical record reviews and retrospective analyses, but offer possible strategies for preventing AMA discharges, which include addressing substance misuse, recognising and managing psychological factors such as anxiety and anger, and using motivational interviewing, which aims to uncover the unspoken motivations behind patients’ behaviours. Mayo Clin Proc 2009; 84: 255-260 Prostate cancer: screening and mortality The controversy surrounding prostate-specific antigen (PSA) testing for prostate cancer has deepened, following the publication of two randomised controlled trials: one from the US, and the other a European collaboration.1,2 In both studies, researchers analysed the effect of regular PSA testing on mortality rates from prostate cancer. In the US study of 76 693 men over 9 years, mortality from prostate cancer was low and did not differ significantly between the tested and untested groups. The authors of this study concluded that the risks of over-screening, diagnosis and treatment are high. In the European study of 182 000 men, the absolute risk difference between the screened and unscreened group was 0.71 deaths per 1000 men. Despite the apparent reduction in rate of death by 20% in the screened group, the researchers comment that the results reflect combined data from a number of trials, the findings are an interim analysis, and the number needed to be screened to prevent one death (1410 men) is high. 1. N Engl J Med 2009; 360: 1310-1319 2. N Engl J Med 2009; 360: 1320-1328 Religion and the end of life Patients who use religious faith to cope with cancer appear to be more likely to receive life-prolonging care in the last days of life, according to US researchers, who conducted a prospective, longitudinal study of 345 patients with advanced cancer. Main outcome measures were intensive life-prolonging care in the form of mechanical ventilation or resuscitation in the last week of life. Patients were initially assessed for the use of positive religious coping, psychological and spiritual measures, advance care planning, and end-of-life treatment preferences. Intensive life-prolonging measures in the last week of life were significantly associated with a high level of religious coping at baseline, even after controlling for advance care planning and other psychosocial confounders. The authors discuss the possible meaning of these findings at length, concluding that clear associations in religiousness and spirituality research are elusive, and that clinicians need to be aware of religious methods of coping when they discuss options with terminally ill cancer patients. JAMA 2009; 301: 1140-1147

Tanya Grassi