Letters

To the Editor: The editorial by Coiera and Westbrook raises some important points.1 Appropriate models of governance (vis-à-vis regulation) surrounding clinical software are required if we are to drive innovative technology on a course that is safe and effective for patients. The success or failure of an information system depends on the organisational context in which it is placed.2 The people, the work processes and the technology must be viewed as integrated elements of one system that aims to improve health quality and, importantly, do no harm. In essence, each element provides an additional layer of quality control and safety, and these work together to avoid adverse events. By law, we require medical practitioners to be registered. By law, we require health facilities to be accredited and licensed. We should also, by law, acknowledge clinical software as being part of the jigsaw puzzle and require that it too be regulated. Because of the complexity of the task, in-house development of clinical systems is unattractive to organisations, leaving vendor solutions as the alternative.3 Currently, there is no apparent active engagement between software developers, government, clinicians and funding bodies to establish a transparent and sustainable program of decision-support software development in Australia.4 Beilby et al recommended a generic standards-based “middleware” that sits outside all clinical desktop software systems and supports the exchange of information with other clinical systems and knowledge repositories.4 This would be the gold standard. Inextricably linked with this would be a regulatory framework to compel software suppliers to comply with the standard. Without this, health care organisations are vulnerable to the whim of software vendors, each with different standards, capabilities and knowledge capital. Decision-support tools to supplement memory and record clinical information and results can help standardise clinical care and reduce human error by ensuring that uniform, evidence-based practices are adopted.5 Electronic decision-support systems are currently espoused as one of the keys to good quality and safe health care.4 The health system needs this innovative technology. However, if the health system is to avoid duplication, fragmentation and inconsistencies associated with multiple standards for electronic decision-support systems and other clinical software, then we must advocate for workable standards and legislative frameworks on which to build the technical solutions. We owe this to the health professionals using these systems, who may otherwise make a wrong turn, and we owe it to the patients at the end of the line.

Karen L Fox BAppSc(HIM)

To the Editor: I wholeheartedly agree with Giles at al1 regarding the need for universal HIV antenatal screening in Australia. However, it is worth noting that, at least in private practice, there is already a significant amount of antenatal HIV screening taking place. In November 2005, several Medicare Benefits Schedule (MBS) item numbers were introduced for antenatal screening for infectious diseases including HIV testing. I am unaware of any specific HIV-testing restrictions relating to national policy (other than the obligations of informed consent and such like) attached to these item numbers. Four MBS item numbers for “microbiological serology during a pregnancy” may include HIV testing (69405, 69408, 69411 and 69413), and one MBS item number (69415) must include HIV testing. From November 2005 to June 2006, there were 137 732 claims for antenatal serological tests, of which at least 46 085 (33%) included HIV testing (see Box).2 There is some variation from state to state (New South Wales, 25%; Victoria, 34%; and Queensland, 38.5%). Significant state-to-state variation of claims for different Medicare items is not unusual but, in this case, it does not appear to follow any pattern (of the epidemiology of HIV infection in Australia). I suspect that the proportion of pregnant women having HIV tests is closer to 50%, assuming that at least some of the other item numbers claimed included testing for HIV. It would be worthwhile taking these figures into account when formulating national policy. Medicare items for antenatal serological testing, which may include HIV testing — number of items processed in Australia from November 2005 to June 2006 by state Item NSW VIC QLD SA WA TAS ACT NT All states 69405 2 664 1 905 1 291 149 919 177 142 269 7 516 69408 2 375 1 191 1 080 115 769 205 170 114 6 019 69411 16 169 5 493 6 758 549 1 890 913 912 284 32 968 69413 15 874 10 267 9 488 2 792 4 171 1 229 588 735 45 144 69415 12 283 10 138 11 695 3 095 6 710 784 424 956 46 085 Total 49 365 28 994 30 312 6 700 14 459 3 308 2 236 2 358 137 732 Item 69415 must include HIV testing.

Len D Moaven

To the Editor: We report three cases of locally acquired Entamoeba histolytica infection in men who have sex with men (MSM) in Sydney, New South Wales. E. histolytica is an invasive pathogenic amoeba that can cause invasive intestinal and extraintestinal amoebiasis. Entamoeba dispar is morphologically identical but is considered non-pathogenic and non-invasive.1 The three patients presented with a 1–3-week history of diarrhoea and abdominal pain. Routine bacterial cultures were negative for pathogens. Ova, cyst and parasite investigations showed cysts and trophozoites of E. histolytica/dispar complex in permanently stained, fixed faecal smears. Stool samples were tested for E. histolytica and E. dispar by polymerase chain reaction (PCR), using a previously described method.2 All three patients were positive for E. histolytica by PCR; sequencing of the amplicons verified the presence of E. histolytica DNA. The three patients presented within a 12-month period in 2005–2006. All were homosexually active men (ages, 31–53 years) who lived in inner Sydney. None had a history of overseas travel within the previous 5 years, suggesting that the infections were locally acquired. High rates of intestinal parasitism are found in MSM throughout the world. Oral–anal and oral–genital sexual practices are reported to predispose to infection with enteric pathogens, particularly protozoa. A 1991 study reported a higher prevalence (37%) of E. histolytica/dispar complex in a homosexual population in Sydney when compared to non-MSM.3 However, that study did not differentiate between the two species E. histolytica and E. dispar. Amoebiasis has become endemic in MSM in Japan and causes significant morbidity and mortality; complications such as colitis and liver abscesses occur more frequently in homosexual and bisexual men than in heterosexual men.4 Similar findings on amoebiasis are reported from Taiwan, with MSM at increased risk for invasive amoebiasis and intestinal colonisation with E. histolytica.5 The discovery of E. histolytica infection in MSM in Australia is of public health concern and highlights the importance of continued surveillance, as the organism has the potential to become endemic in the gay population and to cause significant morbidity. Clinicians should also be aware that E. histolytica is present in urban settings in Australia and should be included in differential diagnoses.

Damien J Stark · Rashmi Fotedar · John T Ellis · John L Harkness

To the Editor: Meningitis is one of the most serious infections in young children. The annual incidence of Haemophilus influenzae type b (Hib) meningitis between 1984 and 1988 was 150 per 100 000 population in Aboriginal children and 27 per 100 000 in non-Aboriginal children younger than 5 years.1 A conjugate Hib vaccination program was introduced in Western Australia in January 1993, before a nationwide program commenced in July 1993. Subsequent marked declines in incidence of Hib meningitis have been reported.2-4 However, there are no recent reports on trends in overall admissions for meningitis. The WA Data Linkage System (WADLS) encompasses statewide population-based record linkage of the statutory birth and death registers, midwives’ notification system, and hospital morbidity database,5 and is one of few such resources worldwide. As part of a larger study to determine the burden of infection in a cohort of births between 1990 and 2000 using the WADLS, we investigated hospitalisation for all-cause meningitis (International classification of diseases, 9th revision, diagnosis codes 003.21, 036.0, 047, 049.0, 054.72, 320-322) in 17 296 Aboriginal and 252 775 non-Aboriginal children younger than 2 years between 1992 and 2000. In Aboriginal infants (< 12 months), the meningitis rate fell by 41% between 1992 and 1993–1994 and by a further 54% in 1995–1996, and has remained stable since (Box). In Aboriginal children aged 12–23 months, rates declined by 44% between 1993–1994 and 1995–1996 and again by 50% in 1997–1998, and no meningitis admissions were reported in 1999–2000. In non-Aboriginal infants, meningitis rates declined by 36%, from 1.8 per 1000 child-years in 1992 to 1.2 per 1000 child-years in 1993–1994, with a further 50% decline in 1997–1998, since when rates have remained stable. Rates declined by 57% between 1992 and 1993–1994 in non-Aboriginal children aged 12–23 months, declined a further 47% in 1995–1996, and have since remained stable at about 0.2 per 1000 child-years. With the decline in meningitis admissions, the disparity between Aboriginal and non-Aboriginal children has narrowed: the relative rate (RR) of Aboriginal to non-Aboriginal meningitis admissions fell from 7.3 in 1992 to 5.0 in 1999–2000 in infants, while in children aged 12–23 months, the RR was > 7.0 in 1993–1996, fell to 3.0 in 1997–1998, and was indefinable in 1999–2000 (Box). In the absence of other relevant interventions, we attribute declines in meningitis admissions to the introduction of Hib vaccine. This is supported by other studies showing a reduction in Hib meningitis following vaccination.2-4 Retrospective data provide an opportunity to assess overall trends in admissions. Future linkages with immunisation and laboratory data will allow us to investigate pathogen-specific admissions and evaluate vaccination programs. Our findings show that substantial improvements can be achieved given government commitment to implement appropriate preventive measures. Adequate funding and continued commitment is needed to ensure these measures are accessible to all WA children. Hospital admission rate for meningitis in Aboriginal and non-Aboriginal children aged (a) < 12 months and (b) 12–23 months in Western Australia, 1992–2000 Relative rate of Aboriginal to non-Aboriginal admissions is shown at the top of each graph.

Hannah C Moore · Deborah Lehmann

To the Editor: The current rate of caesarean sections in Australia (29% of all live births) is higher than the rate in other similarly affluent countries.1 In addition, the rate is continuing to increase; for example, it was less than 20% in 1993.1 Some commentators have suggested that this increase is partly a result of caesarean sections undertaken for non-medical reasons, such as patient demand.2,3 We examined trends in the rates of caesarean section for low-risk women using population-based perinatal data for Queensland over 15 years between 1990 and 2004. Our aim was to assess whether caesarean sections were becoming more common among women with no obvious medical indication for the procedure. The increase in caesarean sections among low-risk women was most dramatic in the private health care sector, where the percentage increased from 10% to 19% (Box). This represents an average annual increase of 4.6% (95% CI, 4.3%–5.0%). In the public health care sector, the increase was less — from 6% to 8% — an average annual increase of 2.4% (95% CI, 2.0%–2.7%). The increase in the private sector in Queensland was similar to the increase reported in the United States.4 The appropriate use of caesarean section, as for any medical intervention, should be based on evidence about the benefits and harm, with doctors, women and their families choosing a method of delivery after considering balanced information on potential outcomes of each method. There is continuing debate about the feasibility of randomised trials to clarify the benefits and harm of caesarean deliveries among low-risk women.2 Opposition to such trials is based mainly on ethical concerns about inflicting a surgical procedure on healthy women based only on randomisation. Non-randomised studies have compared outcomes of caesarean section versus vaginal delivery. However, their results are inconclusive because of the difficulty of distinguishing the effects of factors that influence the selection of delivery method from the effects of the delivery method itself (confounding by indication).3,5 In the absence of randomised trials, non-randomised studies that remove this potential bias by restricting the sample to women who remain at low risk throughout the pregnancy and delivery, according to clearly defined criteria, may provide useful information. They would need to assess both short-term and long-term outcomes. Until such better evidence is available, it is impossible to judge whether or not the current increase in caesarean section rates among low-risk women is desirable. Caesarean section rates among low-risk* women in Queensland, 1990–2004 * Low-risk births were defined as singleton, full-term (37–40 weeks’ gestation), vertex delivery with no reported medical risk factors or complications of labour or delivery, based on a list compiled by Declercq and colleagues.4 Women who had a previous caesarean delivery were excluded from the low-risk group.

Trisha C Johnston · Michael D Coory

To the Editor: The incidence of obesity is rising, and physicians are likely to face the problem of obesity-related glomerulopathy (ORG) recently illustrated by Tran.1 But how can the clinician distinguish ORG from primary (idiopathic) focal segmental glomerulosclerosis (FSGS)? Both may present with nephrotic-range proteinuria, but the prognosis and choice of treatment may differ. To date, the largest published study comparing ORG with primary FSGS is one by Kambham et al.2 In an analysis of 6818 renal biopsies, 71 patients with ORG were identified and compared with a control group of 50 patients with classic FSGS. The study showed that ORG less frequently progressed to end-stage kidney failure, with a 5-year renal survival rate of almost 90% (compared with about 50% in primary FSGS).2 While weight loss can reduce hyperfiltration and albuminuria in ORG,3 spontaneous remission is uncommon in primary FSGS.4,5 Does every obese patient with nephrotic-range proteinuria have ORG and an “indolent” course? The degree of weight loss reported in the case described by Tran may not be achievable or sustainable in most obese patients. Do we have the luxury of waiting to assess the impact of weight loss on proteinuria? In about 50% of patients with primary FSGS, the serum creatinine level doubles after an average of 39 months.2 Furthermore, patients with primary FSGS and nephrotic-range proteinuria who do not achieve remission have a 5-year renal survival of only 50%, compared with almost 100% for those who attain remission.4 In addition, patients treated with corticosteroids (with or without cyclosporin or cyclophosphamide) have higher remission rates (30%–63%) than untreated patients (11%–14%).4,5 Therefore, a delay in introduction of specific therapy is not ideal. There are some clinicopathological differences between ORG and primary FSGS that may help distinguish the two entities (Box). However, Kambham et al found that only two parameters were independently significant: serum albumin level and age.2 Although their study was based on a US population, it serves to demonstrate the principle that the major distinguishing feature between ORG and primary FSGS is the presence of full-blown nephrotic syndrome in primary FSGS (as demonstrated by the severity of hypoalbuminaemia). Obese patients have a similar risk of developing primary FSGS to people in the general population, and patients with nephrotic syndrome (particularly older adults) should not be presumed to have ORG and treated with weight loss alone. Certain pathological findings in a renal biopsy are helpful, but not definitive, in distinguishing ORG from primary FSGS. A biopsy would also exclude other treatable causes, such as minimal change disease. In addition to treatment with angiotensin-converting enzyme inhibitors, immunotherapy should be considered for obese, nephrotic patients, after discussing the potential risks and benefits with a nephrologist. Clinicopathological differences between ORG and primary FSGS* Parameter ORG Primary FSGS Mean age at presentation (years)† 42.9 32.6 Ethnicity White (%) 74 52 African American (%) 21 22 Nephrotic syndrome (%) 5.4 54 Mean 24-hour protein excretion (g) 4.1 6.9 Mean serum albumin level (g/L)† 39 29 Mean serum cholesterol level (mmol/L) 5.9 8.6 Presence of pedal oedema (%) 35 68 Mean degree of segmental sclerosis (%) 10 39 Proportion of cases with glomerulomegaly (%) 100 10 Mean arteriosclerosis score (range, 0–3) 1.34 0.98 Mean degree of glomerular podocyte foot process fusion (%) 40 75 ORG = obesity-related glomerulopathy. FSGS = focal segmental glomerulosclerosis. * Adapted from Kambham et al.2 † Independently significant.

Andy K H Lim

To the Editor: Recent articles in the Journal by Kurrle1 and Finn and colleagues2 referred to advance care directives aiding the management of acute illness in elderly residents of aged care facilities. It is our experience that these directives are often unhelpful in elderly patients and, outside certain progressive medical conditions, can result in triage of elderly patients to inappropriate lower levels of care. In chronic medical conditions where the clinical course allows time for patient or family understanding, and the course of organ failure is predictable, then certain supportive but ultimately futile therapies can be avoided by instituting an advance care directive that specifically excludes them. However, these directives are less helpful in acute illnesses. They usually refer to “intensive care”, and “life support”, sometimes specified as mechanical ventilation, dialysis or cardiopulmonary resuscitation. These “general” advance care directives fail, as they assume that prognosis is immediately apparent, and that treatment is “all or nothing”, both of which assumptions are clearly untrue. Determining an accurate prognosis for recovery from a critical illness is difficult and takes time. It involves diagnosing the cause of the illness, quantifying the severity of comorbidities and, most importantly, assessing response to initial treatment. Whether severe sepsis is arising from the urinary tract or abdominal cavity may not be apparent initially. Many elderly patients survive severe septic shock caused by urosepsis with haemodynamic monitoring and short-term high-dose vasopressors. It is also not possible to distinguish which patients with severe respiratory failure will respond to non-invasive ventilation. We followed up critical care patients aged 75 years and over who survived to hospital discharge over a 12-month period and confirmed that acceptance of critical care admission in elderly people is high (unpublished study; details available from the authors). This is the very population that, in our experience, frequently says they do not want to be placed on “life support”, if asked when well. Together with the fact that an accurate prognosis takes time, then a prudent approach should begin with the presumption of aggressive treatment for acutely unwell elderly patients, rather than a presumption of limited therapy or palliation. Advance care directives that refer to therapies need to be specific and to recognise that critical care therapy can be graduated and readily terminated once a more accurate prognosis is known. Furthermore, some critical care therapies, such as non-invasive ventilation and high-concentration oxygen, can significantly improve patient comfort while management plans are formulated. In our experience, patients and their families are often very surprised when they understand the full implications of an advance care directive that refers to generic therapies, such as cardiopulmonary resuscitation and “intensive care”.

Andrew W Holt · Alnis E Vedig

To the Editor: I note with interest Australian medical students’ difficulties in gaining access to patients, as documented by several authors in recent months.1-3 There is an alternative explanation for this paucity of access, and that is the culture in Australian teaching hospitals. I graduated from the University of Otago Dunedin Medical School in New Zealand 9 years ago, and had a somewhat different experience. The hospitals attached to the Dunedin Medical School were the equivalent of one medium-sized acute hospital in Australia, one rehabilitation hospital, and a small peripheral regional hospital. These facilities taught up to 200 clinical medical students — a high student-to-patient ratio. However, we did not face the barriers that Australian students face in gaining access to patients, and so still had a world-class medical education. The system in Otago differed from that in Australia in several ways. If a patient was having an investigation, we accompanied them. Likewise, if they were seeing a staff member, we would often stay. There was a culture where every patient admitted to hospital expected to see a medical student. We approached the patients directly to ask permission to see them, rather than being turned away by nursing staff. Consequently, in non-obstetric patients, I encountered only one refusal to see me in my clinical years, and this was after I had started taking a history and asked about tranquilliser use in too much detail! We also did not wait to see only patients who were ideal teaching cases — patients who speak English, do not have dementia, are not unwell, are not busy, and who have a particularly interesting condition are rare anywhere. If a patient had dementia or was unwell we familiarised ourselves with their history, then saw the patient over the course of several days. If there were visitors, we asked about an appropriate time to come back. We saw all routine cases, as these reflect the real workload of doctors. By comparison, in my years as a resident and registrar in Australia, I have seen very few medical students, and have seen many teaching and learning opportunities pass by. In conclusion, we need to examine the role of medical students closely, and look at ways to facilitate their access to existing patients. There is something to be learned from all patients admitted to hospital. The culture of teaching hospitals and the expectations of students, staff and patients should reflect this fact.

Sarah J Abrahamson

To the Editor: The 2005 Cochrane review Home-like versus conventional institutional settings for birth1 has been cited in the public media to claim that birth centres are less safe than labour wards as there was an increased risk of a baby dying during or immediately after childbirth.2 This “headline-grabbing” statement is false. Firstly, this finding from the systematic review did not reach statistical significance.1 Secondly, the outcomes reviewed were related to the allocated place of birth, not the care provided. This fact is critically important, as 48% of women who were booked to have their baby in a birth centre did not give birth there.1 This is a predictable effect of the intention-to-treat principle. However, such high rates of “treatment contamination” negatively affect confidence in the study results.3 Additionally, the vast majority of baby deaths examined in the Cochrane review happened before labour and thus had nothing to do with care during childbirth. One might wonder whether there was a real increased perinatal mortality rate resulting from delayed transfers from birth centres.1 The analysis found 41 deaths in total, but only six that occurred in normally formed babies who reached term (these are the only babies who are eligible to be born in a birth centre). Three of these deaths were associated with birth centre care, and three with standard labour care. The interpretation of this Cochrane review raises questions about the validity of the underlying randomised controlled trials. In this experimental design, researcher control should ensure that people receive the specific treatment that was planned for them (treatment fidelity).4 The Cochrane handbook gives no guidance as to how to evaluate either the quality of the researchers’ definition of the planned treatments, or the fidelity between the treatments provided and the researchers’ plan.3 Most of the trials that formed the basis of the Cochrane review did not adequately define their treatments, nor adequately control the treatments provided to either group. It is not clear how the birth centre trials could sensibly be considered to have been scientifically controlled. The reviewers attempted to deal with this critical point by claiming that they were looking only at the effect of the “setting”, but their question clearly states that they were examining the effect of “care within a setting”.1 We conclude that the Cochrane review of the setting for birth is unreliable because of the weaknesses of the underlying trials. Rather than using questionable research to attack birth centres, it would be more constructive to engage in rigorously designed research that could provide robust evidence on the safety of all forms of maternity care, including standard medical care.

Kathleen M Fahy · Sally Tracy

In reply: Fahy and Tracy highlight the lack of high-level evidence about the relative safety of different models of maternity care. But in criticising the Cochrane review, it is important not to “shoot the messenger”. There is no doubt that the Cochrane review is not ideal but, like it or not, it remains the best evidence we have. The review of 8677 women in six randomised trials found a relative risk (RR) of perinatal death of 1.83 (95% CI, 0.99–3.38) in birth centres versus conventional institutional settings. In the 3332 pregnancies assigned to continuity of care by midwives who did not also work in conventional delivery suites, the RR was 2.38 (95% CI, 1.05–5.41).1 It would be fair to say that such findings should lead to real concerns about lack of safety rather than reassure the unbiased observer. Other published evidence has raised similar concerns. A retrospective review of over 183 000 low-risk births in Stockholm, Sweden, found a statistically significant fourfold increase in intrapartum fetal mortality in women planning birth centre care compared with those planning standard care (three intrapartum deaths in 3256 babies of women planning birth centre care versus 36 deaths in 180 380 babies of those planning standard care).2 The increase in intrapartum mortality was almost sevenfold for primigravidae. These findings led to evidence-based changes in the organisation of the birth centre involved to minimise the identified risks. To paraphrase Fahy and Tracy, rather than criticising the best available evidence reviewing birth centre outcomes, it would be more constructive to engage in rigorously designed research to assess how risk might be minimised in all forms of maternity care.

Andrew F Pesce

To the Editor: I was very concerned to read the letter from Mazza et al1 regarding “positive” family planning and feel I must make a comment. The authors are well known for their work in the area of women’s sexual and reproductive health, but I would like to challenge some of the points they have made. The first point: whether intervention by general practitioners would be appreciated by younger women not yet interested in motherhood. I believe it is part of the role of doctors to inform, even when a person may not be ready for the information. Telling 20-a-day smokers that they are not doing their body any favours doesn’t go down well with some people, but even this brief intervention can change behaviour and save lives. The second point: whether GPs can respect patients’ autonomy. Every day I speak to women who have been offended and upset by doctors who have said something awkwardly, or imposed their own values, or been downright offensive. That won’t change, and recommending that well informed and tactful doctors wait before imparting vital information until the rest of the world lifts its game means we will all be waiting a long time. Part of the art of medicine is judging the audience and knowing the perfect point in a consultation to speak, and how to say it. What can be more appropriate, when seeing a woman in her late 20s who has requested a repeat prescription for the contraceptive pill, than to ask casually (as one is unrolling the sphygmomanometer cloth), “So, do you think there might be any children in your future?” The usual response, as detailed in Cannold’s book,2 is an emphatic “yes”. The next question, “Have you got a time scale when you would be looking at that?”, may give the opportunity to mention such things as rubella vaccination, smoking and folate supplements. And if the woman indicates that pregnancy would be on her to-do list at age 38, then a reasonable and non-harassing response could be, “Could we talk about fertility rates at that age?” The third point: doctors reinforcing the dominant paradigm (of years ago) of the woman as childbearing machine, by asking about a woman’s intentions. This seems to me as misguided as not asking about suicidal ideation in case we make it happen. By all means do research, but don’t ask doctors to be silent about this important issue until the sociologists have spent another 10 years on it. By that time, it will be too late for a lot more women.

Angela M Cooney

To the Editor: Since my article on medical abortion was published in the Journal,1 I have received some information from colleagues, and from women who have undergone abortions, about the current practice of medical abortion in Australia. I believe this may be of interest to readers of the MJA. More than a dozen practitioners have informed me that they have used misoprostol or methotrexate/misoprostol combinations to induce early abortion (before 9 weeks’ gestation) outside of hospitals, and a number of women have reported undergoing such abortions. The number of cases involved in this anecdotal sample is at least several hundred annually. Induced abortion using methotrexate/misoprostol was practised in the United States up until the introduction there of mifepristone/misoprostol regimens in 2000.2,3 There is wide experience of this drug combination reported in the medical literature, and the consensus is that, in the short term at least, it is safe and effective, although less effective than the mifepristone/misoprostol combination.2-4 Both drugs are licensed for purposes other than abortion in Australia, as elsewhere (misoprostol for treatment of gastric ulceration; methotrexate as a cytotoxic agent, and for psoriasis and rheumatoid arthritis), but the use of drugs “off-label” is an acknowledged medical practice.5 Misoprostol in particular is widely used in obstetrics for cervical ripening and treatment of postpartum haemorrhage.5 These early abortions take place “under the radar” in the sense that there is no specific Medicare item number; the administration of the drugs occurs in the course of a standard consultation. There is nothing irregular about this, but it does mean that the inaccurate data we currently have on the number of abortions performed in Australia are even more inaccurate than initially thought. It should be noted also that misoprostol alone or in combination with other prostaglandins is being used in Australian hospitals, as overseas, in a more evident manner for the induction of late abortion in cases of severe fetal abnormality detected after 13 weeks’ gestation.5 As well, methotrexate is commonly used in the treatment of early, unruptured ectopic pregnancy, in doses well below those used in oncology. The communications I have received on the subject lead me to believe that medical abortion is currently extensively practised in Australia.

Caroline M de Costa

To the Editor: The Australian Fracture Prevention Summit held in 2002 recognised osteoporosis as a major public health issue. Despite this, several Australian studies have found that a majority of patients with osteoporosis-related fractures do not receive appropriate evaluation and treatment as recommended by the clinical guidelines.1-4 In 2003, the Queen Elizabeth Hospital, a tertiary referral hospital which services the north-western suburbs of metropolitan Adelaide, implemented a novel approach to improve the secondary prevention management of patients admitted to the orthopaedic unit with fragility fractures. The strategy was based on the “plan-do-study-action” principle of medical quality improvement, with the primary goal of enhancing performance.5 Before commencing, a retrospective case-note review of 40 consecutive patients who had been admitted to the orthopaedic unit with osteoporotic fractures revealed that, at discharge, none were receiving any medication for osteoporosis. Patients over the age of 50 years who had been admitted with fragility fractures were identified from computer records. With the support of a physician and junior medical staff, a clinical pharmacist provided individual counselling, written materials and osteoporosis therapy. The rate of medication prescription was initially assessed at discharge. In a follow-up telephone interview, participants were queried about the continuation of osteoporosis therapy, performance of investigations by general practitioners, and history of falls. Over a 10-month period, of 259 patients admitted with fragility fractures, 228 patients (88%) were prescribed osteoporosis therapy (calcium, vitamin D and risedronate) on discharge. Of those eligible, 65 patients participated in the follow-up audit. Forty-eight patients (74%) continued to take medications for osteoporosis as initially prescribed; only 28% had had laboratory investigations for osteoporosis and 31% a bone mineral density test. In addition, three patients had experienced recurrent falls complicated by further fragility fractures. The appointment of an allied health champion with clinical backup from a general physician appeared to have achieved a high level of initiation and continuation of osteoporosis pharmacotherapy in at-risk patients during hospital admission. The low rate of follow-up investigations is consistent with previously published data suggesting poor community-based follow-up after hospital discharge of patients admitted for osteoporotic fractures. The major limitation of this clinical pathway is the low rate of patient participation in the follow-up audit. Therefore, the results of follow-up data cannot be said to be representative of the cohort. This study highlights the importance of the participation of GPs in maintaining patient compliance with hospital-initiated programs, especially those involving chronic illnesses.

Tim Yu-Ting Lu · Jennifer A Pink · Lauren E Whitten · Catherine L Hill · Robert J Adams · Catherine Gibb

To the Editor: The Experimental Drugs Section (EDS) of the Drug Safety and Evaluation Branch of the Therapeutic Goods Administration (TGA) administers the clinical trial notification (CTN) and clinical trial exemption (CTX) arrangements for unapproved medicines used in clinical trials. These arrangements provide an avenue of “exemption”, whereby medicines that have not been approved for marketing in Australia are able to be supplied to patients within the context of a clinical trial approved by a human research ethics committee working under the guidelines of the Australian Health Ethics Committee (a subcommittee of the National Health and Medical Research Council). Although these arrangements cover only clinical trials in which unapproved medicines are used, a substantial number of such trials are carried out in Australia each year. (Clinical trials using unapproved medical devices that also use the CTN/CTX arrangements are administered by the TGA’s Office of Blood, Devices and Tissues and are not included in these statistics.) The EDS often receives queries from stakeholders requesting some form of basic statistical data with respect to clinical trial activity in Australia. The EDS intends to begin use of a new database in 2007 for recording CTNs and CTXs notified to the TGA. It is hoped that this will enable us to publish a basic statistical subset of clinical trial information on an annual basis. As a prelude to this capability, we have manually compiled a few simple statistics on clinical trials notified within the financial year 2004–05. Box 1 breaks down the trials conducted into various body systems or treatment areas. There were 739 separate clinical trials of unapproved medicines commenced over the 1-year period. As many of these are multicentre trials, there are a much greater number of actual trial sites involved. (A good measure of the number of trial sites is simply the raw CTN notification figures, numbering 2776 for the same period.) Box 2 breaks down the trial numbers into the various phases of drug development. Although this is not relevant to all trials, these figures give an indication of the main areas of drug development research currently being conducted in Australia. Given the number of multicentre trials being carried out, we did not think it useful to break down trial numbers by state and territory. We trust that these data convey some idea of current clinical trial activity with respect to unapproved medicines in Australia. 1 Clinical trials of unapproved medicines, by body system and therapeutic area, July 2004 to June 2005* Body system/therapeutic area Number of trials Neoplastic disorders 252 Cardiovascular system 78 Central nervous system 71 Immunology 64 Endocrine and metabolic disorders 60 Infections and infestations 42 Musculoskeletal system 36 Genitourinary system 28 Analgesia 20 Respiratory system 16 Alimentary system 15 Skin 13 Eye 7 Surgical preparations 5 Nutrition 3 Ear 2 Unspecified† 27 Total 739 * Based on clinical trial notification and clinical trial exemption data. † “Unspecified” refers either to trials that were not directed toward a body system or trials in which the system could not be determined from the information on the clinical trial notification form. 2 Clinical trials of unapproved medicines, by trial phase, July 2004 to June 2005* Trial phase Number of trials Phase 1 87 Phase 2 259 Phase 3 277 Phase 4 53 Other† 63 Total 739 * Based on clinical trial notification and clinical trial exemption data. † “Other” denotes trials that were not nominated in a particular phase or to which these designations were not relevant.

Jonathon Rankin · Jenny Mason · Neil Kottege · Natasha Y Andersson

The recent viewpoint by Kamien1 is timely, given Food Standards Australia New Zealand is currently advocating for the mandatory fortification of all bread-making flour with folic acid (80–180 μg per 100 g of bread). The proposal is now before the Australia and New Zealand Food Regulation Ministerial Council, and a decision is imminent. In 1991, the Medical Research Council Vitamin Study Research Group reported a randomised double-blind trial conducted at 33 centres in seven countries. Periconceptual folic acid supplementation had a 72% protective effect against neural tube defects (relative risk, 0.28; 95% CI, 0.12–0.71).2 Because folic acid supplementation is ineffective when started after the pregnancy is confirmed, fortification of staple foods such as bread remains best practice. The United States started mandatory fortification of enriched cereal-grain products a decade ago. As expected, there has been an increase in the population geometric mean concentrations of serum folate and red blood cell folate,3 and a corresponding reduction in the number of babies born with debilitating neural tube defects.4 The benefits are clear and the risks are vague. Historical concerns that folic acid supplementation could mask pernicious anaemia and cause cancer have not been substantiated by international experience in more than 50 countries. Australian health professionals have a brief window of opportunity to join Maberly and Stanley5 and advocate for mandatory fortification in spite of commercial objections, which are based on market-share concerns for existing “designer” products. If we educate and inform our patients and the community at large, the decisionmakers should finally get the message and this cheap, safe and effective public health policy would be implemented — a decade overdue.

Hasantha Gunasekera

To the Editor: Tan et al1 found that patients value key elements of successful weight management, including advice on healthy eating and exercise and regular follow-up. Accredited practising dietitians (APDs) provide all of these things and have the qualifications, skills and time to work with people to effectively manage weight. APDs use the Obesity Best Practice Guidelines of the Dietitians Association of Australia, providing evidence-based dietary therapy. By working alongside general practitioners to provide individual advice, APDs ensure the best outcomes for patients. A considerable number of patients surveyed said that referral to a dietitian would be useful and that they would be likely to follow their GP’s advice if referral was recommended. The weight management roles of GPs and APDs are complementary and, by addressing any patient concerns and providing a referral to an APD, GPs can help their patients achieve their weight management goals.

Claire Hewat

To the Editor: Trans fats are produced by partial hydrogenation of liquid vegetable oils to produce oils which are more solid at room temperature and have better physical properties for food processing, such as increased shelf-life. Trans fats represent a major dietary cardiovascular disease risk, with as little as 5 g daily increasing the risk of ischaemic heart disease by 25%.1 A recently published survey of the trans-fat content of French fries and chicken nuggets purchased from two international fast food chains in 20 countries emphasises the wide variability of trans fats in different countries.2 This work highlights the potential health risks imposed by the industrially generated trans fats in these food products. Of the sampled French fries and nuggets, 20 of 39 samples from 19 different countries yielded trans-fat levels in excess of 5 g for an average serve. Interestingly, the report included no data from Australia. We have evidence that similar fast foods have substantial quantities of trans fats (putting Australia in the mid-range of the league table). The only available published results are those reported by the Australian Consumers Association (ACA) in 2005.3 The ACA tested 55 foods and found 18 had trans-fat levels greater than 2% of total fat. The interesting issue is that the ACA data show a variation in trans-fat levels of greater than 22-fold (0.8%–22.5% of total fat) in popular fast foods. Data on trans-fat levels should be available on all foods in this country, whether sold in supermarkets or to the food service industry. However, at present, there is no requirement to include trans-fat content on nutrient information panels, except when the manufacturer wishes to make a nutritional claim about cholesterol, saturated, unsaturated or trans-fatty acids.4 Many countries, including the United States, Canada and some European countries, have either placed limits on the permissions for trans fat in processed foods, or, more commonly, mandated labelling requirements. The most notable is Denmark, where legislation restricts maximal industrially produced trans fats to less than 2%.5 Not surprisingly, that country reported markedly lower trans-fat contents in fries and nuggets than those sold in Australia.2 Despite review of the “Australia New Zealand Food Standards Code”, labelling of the trans-fat content of food has not been mandated,4 and consumers and health professionals wishing to reduce their trans-fats intake remain unable to make informed choices.

David Cameron-Smith · Andrew J Sinclair

To the Editor: With obesity reaching epidemic proportions in Australia, professional education needs to reflect this increase in prevalence. Research has shown that health professionals’ lack of knowledge is a common barrier to providing care for overweight and obese individuals.1-3 We investigated the coverage of obesity education in university medical, dietetic and nursing curricula (partially replicating the earlier study in the Journal by Campbell and Welborn4), and also the extent to which obesity was covered in the curricula of selected professional specialist colleges in Australia. Contact hours for obesity were compared against two “control diseases”, diabetes and depression. Surveys were sent to 15 medical schools, and administrators of six dietetic courses and six nursing courses in Australia. The survey asked questions including the total number of contact hours in the course for each topic, and if additional teaching was needed. Most college curricula were publicly available, as were the Continuing Medical Education events and topics. Nine of the 15 medical schools and three of the six dietetic and nursing courses returned the questionnaire. Because of the nature of the data and the very small sample sizes, no statistical analysis was conducted. In the medicine curriculum, while variation in mean contact hours between obesity, diabetes and depression was small, the range was quite large (Box). There was also wide variation in the contact hours for obesity education in the nursing curriculum. The median contact hours for obesity education were half that of both depression and diabetes, and one university reported zero contact hours for obesity education. With the exception of the Royal Australian College of General Practitioners, the colleges surveyed did not include obesity in the prescribed teaching curriculum. Several professional education topics were available on obesity, but considerably more were available relating to diabetes and depression. Our findings indicate that most of the universities appear to provide undergraduate students with adequate contact hours for education about obesity. The professional training provided by the individual specialist medical colleges is not as comprehensive, and lacks specific obesity education. Based on these findings, more systematic research is needed to examine the details of training and to develop programs which better equip health professionals to deal with the growing burden of obesity and related diseases. Future research should not be limited to measuring contact hours — the focus should extend to investigating the content of courses and professional development programs, and to examining the barriers to including obesity education. Summary of median, mean, standard deviation and range for contact hours of teaching about obesity, diabetes and depression in undergraduate courses Course and disease Number reporting contact hours Contact hours Median Mean ± SD Range Medicine Obesity 8 7 13 ± 11 5–30 Diabetes 8 13 20 ± 20 6–64 Depression 6 13 13 ± 5 4–20 Nursing Obesity 3 6 8 ± 10 0–19 Diabetes 3 13 18 ± 8 10–25 Depression 3 13 16 ± 10 8–28 Dietetics Obesity 3 15 14 ± 8 6–22 Diabetes 3 20 17 ± 8 8–23 SD = standard deviation.

Melissa J Hayden · Leon Piterman · John B Dixon · Paul E O'Brien

To the Editor: The discussion of fibrinolysis in the recently published guidelines for the management of acute coronary syndromes 20061 is interesting. The recommendations clearly indicate that second-generation agents should be preferred to streptokinase in all circumstances. The guidelines reference the GUSTO-I trial data2 as the primary support for those recommendations. These data are, at best, debatable in terms of showing any benefit of front-loaded tissue plasminogen activator over streptokinase, and then only in limited circumstances (ie, patients aged less than 75 years with anterior infarcts and within 4 hours of the onset of symptoms).3,4 To my knowledge, there have been no head-to-head trials of this size of the other fibrinolytic agents discussed against streptokinase. Thus there is no justification for the blanket superiority that is accredited to these agents, both by implication and explicitly, in the guidelines. It is a matter of some concern that guidelines from such respected groups should make statements that will be used broadly by clinicians, but that go beyond the evidence base to which they refer. On the balance of information available there is no compelling case to relegate streptokinase from the front line.

Andrew J Bezzina

In reply: As Bezzina states, the GUSTO-I trial is the main source of evidence for the superiority of front-loaded alteplase (rt-PA) over streptokinase, showing a 1% absolute and 15% relative benefit.1 Subgroup analysis suggested that only certain groups benefited, but this is an inappropriate use of subgroups, and the result should be applied overall. A clear mechanistic reason for the advantage of rt-PA — greater 90-minute full coronary patency — has also been demonstrated.2 Meta-analyses of the percutaneous coronary intervention (PCI) trials in acute myocardial infarction have all shown benefit over fibrinolysis. However, the benefit of PCI is greater compared with streptokinase than with plasminogen activators.3 Although not providing a head-to-head comparison, these data also support the superiority of plasminogen activators over streptokinase. The second generation plasminogen activator studies have all compared these with the “gold standard” front-loaded rt-PA. These agents have been shown to not be inferior in relation to mortality,4,5 and tenecteplase showed a decrease in systemic bleeding.5 Administration as a bolus without the adverse reactions commonly seen with streptokinase (such as hypotension) make them much more convenient and safe, particularly in smaller institutions. In addition, streptokinase is an inappropriate choice in Indigenous patients because many have high levels of anti-streptokinase IgG and streptokinase resistance.6

Philip Aylward · Constantine N Aroney · Ken Hossack · Andrew M Tonkin

To the Editor: We are delighted at the attention which the editorial by Hickie and Blashki1 has drawn to our clinical update on the management of bipolar disorder in general practice.2 However, we are bemused by a number of the sentiments, criticisms and statements of fact included in that robustly expressed editorial. We will focus only on a few of the major issues raised. Hickie and Blashki argue that there are too many “worthy” guidelines promulgated to general practitioners by “specialist colleagues” across the range of medical conditions, and that extrapolation from specialist centre studies “may particularly annoy GPs”. On the other hand, they bemoan the fact that “few [guidelines] have targeted general practice”. We are surprised by this insinuation that such issues pertain to our clinical update. Three of the authors of our article are GPs in either clinical or academic practice, and the document has been formally endorsed by the Royal Australian College of General Practitioners. Our article focuses on the practical issues concerning the role of the GP in the management of patients with bipolar disorder, and deals frankly with the respective contributions of the GP, psychiatrist, and psychologist. It is our experience that GPs are enthusiastic in enhancing their skills in the management of mental illnesses such as bipolar disorder in the primary care setting. Therefore, we have little doubt that updates such as ours will be viewed as helpful aids for GPs, who are often the main “port of call” for people with this condition. We strongly contend the statement that we ignore practice-based issues and thereby risk “an overall negative rating from the target audience”. Hickie and Blashki state that “the most useful mental health guidelines tackle the tough issues”, such as sources of self-help, self-monitoring, detailed illness descriptions, family education, quality e-health resources, and guidance when patients become a danger to themselves and others. We fail to understand the implication that our update does not address such issues, as these very practical matters are clearly highlighted in detail in our article. Finally, we are surprised at the negative tone concerning guidance for the management of mental illness in general practice by authors who have argued strongly for the value of evidence-based guidelines in specialist psychiatric practice.3 Although (as we clearly acknowledge) there is currently a limited evidence base for managing such conditions in primary care, there is still a major need for practical guidance for the practitioner in this setting.

Philip B Mitchell · James A Best · Bronwyn M Gould · Ian G Wilson

To the Editor: Hickie and Blashki are to be commended for their view that clinical practice guidelines in mental health should be relevant to a primary care setting.1 Unfortunately, such guidelines have little effect on clinical outcomes, as most general practitioners have not been taught how to use them to their best advantage.2 There is also little known about the best way to implement guidelines in mental health, let alone in primary care mental health settings.3 As a result, more guidelines, even those more attuned to the primary care environment, will be of little benefit to our community. The Royal Australian and New Zealand College of Psychiatrists (RANZCP) is actively promoting the use of clinical practice guidelines4 as a quality improvement tool that will allow mental health practitioners (including GPs) to assess their practice more carefully and measure and analyse variance. The next step is to fund research into how best to implement mental health guidelines at the coalface. It is only through practice-based research that the barriers to successful implementation of evidence-based practice can be identified and overcome. Such research could be funded via a National Health and Medical Research Council (NHMRC) or Australian Research Council (ARC) grant program and coordinated by groups such as the RANZCP or the National Mental Health Working Group Safety and Quality Partnership Group. Mental health has already been identified as a grant funding priority by the ARC.5 Once this has been achieved, then training and mentoring to help practitioners review their practice as part of a quality improvement framework is required, rather than more guidelines per se. Providing well researched, up-to-date and accessible information for GPs on “self-help, self-monitoring, [and] detailed illness descriptions”, as suggested by Hickie and Blashki, is commendable, but is not what is required for guidelines to truly improve the safety and quality of mental health care in Australia.

Andrew J Wilson · David Barton

To the Editor: With Australia’s rapidly ageing population and an explosion in the number of retirement villages and nursing homes, Finn and associates are to be congratulated for ventilating the subject of the interface between residential aged care facilities and emergency departments.1 My experience of emergency department (ED) and aged care facility relations spans over 50 years and I have been involved in both sides of the equation. Firstly as a surgeon, then as director of an ED, and finally, as a resident of a retirement village for over 20 years (including, for my wife, 5 years in the affiliated nursing home), and during that time my wife and I have had at least eight episodes as patients in an ED. Retirement villages and nursing homes are not equipped or organised to handle medical or surgical emergencies. Problems of “disposal” arise after ED assessment and treatment in a public hospital. The hospital may not have an empty bed. The patient’s condition may not be serious enough to require a hospital bed, but the patient may not be well enough to return to his or her retirement village. Privately insured patients may have the option of transferring to a private hospital but usually spend an unnecessarily long time in the ED awaiting such transfer. Matters that need attention are: a standing arrangement between public and neighbouring private hospitals to facilitate quick transfer of suitable patients. the removal of long delays in EDs that occur while waiting for the results of investigations and even longer periods awaiting “higher opinions” after receiving these results. a speedier and more detailed hospital summary addressed to the general practitioner (if known) as well as to the aged care facility concerned.

Keith S Jones

To the Editor: A nationwide colorectal cancer (CRC) screening program will commence in 2006. It has been shown that general practitioners can influence their patients in the decision to have CRC screening.1,2 There are several screening test options in Australia, and the relative geographical isolation of rural centres may influence attitudes and participation. We sought to determine the attitudes of GPs towards CRC screening and test preferences. Between January and September 2005, all GPs in Western Australia (n = 1837; 1298 metropolitan, 539 rural) were sent a questionnaire, which was completed by 801 (43.6%). Overall, 62.8% of respondents believed that asymptomatic average-risk subjects should have CRC screening (67.1% of metropolitan GPs v 54.2% of rural GPs; P = 0.003). The questionnaire revealed major differences between which test GPs would recommend for their patients and which test they preferred for their own personal screening (Box). These differences were related to the factors GPs believed were most likely to influence choice of screening test. For colonoscopy, accuracy and speed of result were considered most important; for faecal occult blood testing, no need for bowel preparation or time off work and no discomfort were considered the strongest determinants. Previous studies that included patients’ views have found that physicians may incorrectly perceive certain factors in screening to be important to their patients.3 There were no significant differences in choice of test between rural and metropolitan GPs. Although the target age group for the Australian pilot study and the national screening program is 55–74 years,4,5 two thirds of GP respondents felt screening should be offered from the age of 50 years, and a quarter believed it should continue beyond 80 years. Many GPs (65%) indicated they would like further education on CRC screening. In summary, there is good support for CRC screening among Western Australian GPs, but the availability of different screening tests and variations in GPs’ opinions are likely to significantly influence clinical practice. Colorectal cancer screening methods and general practitioners’ recommendations and attitudes Test recommended by GP for patients GPs’ perception of patients’ choice of test GPs’ preferred test for their own screening Faecal occult blood testing 430 (53.7%) 396 (49.4%) 236 (29.5%)* Colonoscopy 285 (35.6%) 278 (34.7%) 479 (59.8%)* Flexible sigmoidoscopy 37 (4.6%) 20 (2.5%) 20 (2.5%) Computed tomography colonography 18 (2.2%) 69 (8.6%) 32 (4.0%) Barium enema 0 2 (0.25%) 3 (0.4%) * P = 0.004 (χ2)

Graham B Turner · Marcus W Chin · Noellene M Foster · Jon Emery · Geoff M Forbes

To the Editor: Australia’s imminent bowel cancer screening program will revolve around the general practitioner,1-3 whereas, in the United Kingdom, the GP will have virtually nothing to do with the national screening program now underway.4 It is curious that two programs with the same evidence base regarding effectiveness should be so fundamentally different. One explanation could be the differing health care systems in each nation. However, they are more alike than not, so the true explanation for the Australian methodology could rest with the outcome of the Australian pilot studies. If that is the case, then perhaps one should be both alert and alarmed. Given the inequity in access to GPs in Australia, it is not surprising that the Final Evaluation Report5 of the pilot national screening program stated that: Some GPs interviewed in Woolcott’s Qualitative Research focus groups . . . expressed concern over access to FOBTs [Faecal Occult Blood Tests] for people without a fixed address. It was mentioned that this group, particularly Aboriginal and Torres Strait Islander people and people in low socioeconomic groups, particularly homeless people, did not receive invitations to participate in the Pilot. Some GPs commented that the information packs, in both English and the translated versions, were too complicated for people with low literacy and those from culturally and linguistically diverse backgrounds.5 The same report noted that 38% of people overall (men, 42%; women, 34%) and 52% of non-English speakers did not visit their GP after a positive FOBT. Nevertheless, the report favours the continued central role of the GP.5 This is not the case in the UK screening program, which has a more direct approach, with program hubs and associated screening centres — all with defined accountabilities. The Australian approach is to simply add to the workload of GPs — a more pragmatic approach in the short term, but less imaginative. Our program will undoubtedly be a step forward in colorectal cancer prevention. The question is how large that step will be. Reliance on the existing system threatens to reinforce existing health care inequities.

Allan D Spigelman