Letters

Therese M Foran Medical Director, FPA Health, 328–336 Liverpool Road, Ashfield, NSW 2131. terrifashATfpahealth.org.au In reply: Mea culpa! Essure is, of course, a hysteroscopic rather than a laparoscopic method of female sterilisation and is described so in the text of the article. I apologise for not picking up this error while checking the proofs. Kerin is also correct in pointing out that Essure is made not from pure titanium but from a titanium alloy. The possible adverse effects, though rare, are listed among a number of others in the manufacturer’s information brochure.1 I am always extremely wary of ascribing a 100% effectiveness rate to any contraceptive method. Since Essure has been used so far on only small numbers of women, the figure I quoted was the upper limit of the failure rate in world literature for female sterilisation procedures.2 Although initial experience indicates that the eventual success rate should be very close to 100%, Kerin’s quoted 95% CI suggests that, at present, we can only promise potential Essure users a better than 99.5% effectiveness rate (ie, a failure rate quite close to the figure I used). I consider Essure to be an excellent new method of permanent contraception, and apologise if my article gave any other impression. I am certain that Australian women and their doctors will increasingly consider it an option in the future.

Therese M Foran

David H Eizenberg Obstetrician and Gynaecologist, Macquarie Chambers, 183 Macquarie Street, Sydney, NSW 2000 To the Editor: In their recent article on treatment of menstrual disorders, Hickey and Farquhar described three case scenarios to highlight alternative treatments for menstrual disorders.1 In Patient 1, a 39-year-old woman with dysfunctional uterine bleeding, the authors preferentially treated the patient with the levonorgestrel-releasing intrauterine system (20 μg per 24 h). Unfortunately, this device is available through the Pharmaceutical Benefits Scheme only for contraception, not treatment of menorrhagia. It would be difficult to explain to the government its use in this woman, who, according to the history, had had laparoscopic sterilisation. As a new intrauterine system has to be inserted every 5 years, and has a failure rate of 20% after 1 year, a 39-year-old woman would need at least another two inserted to control dysfunctional bleeding. The optimum method of management would have been simple vaginal hysterectomy. This was not mentioned in the article, which contrasted the intrauterine system only with abdominal hysterectomy. The authors also claimed that “cost–benefit analysis showed that [the intrauterine system] Mirena was three times cheaper than hysterectomy”. This analysis should include the cost of three Mirenas ($260 each), insertion, doctors’ visits for Pap smears for 30 years, tampons and pads. Is this cheaper? After all, hysterectomy means no periods, pain, pregnancies, Pap smears or pads. What is wrong with vaginal hysterectomy? The fact that the woman had had three caesarean sections and laparoscopic sterilisation was not a contraindication.2 Patient 2, a 45-year-old woman with menorrhagia and small fibroids, could also have been managed with vaginal hysterectomy.3 There is no evidence that hysteroscopic resection of fibroids in a multiple-fibroid uterus, as recommended by the authors, will improve menorrhagia. They also state that an alternative technique, embolisation, has been “widely used”. This technique is experimental and, as they state, “has been associated with serious side effects, such as infection, bowel obstruction and loss of ovarian function”, as well as death.4 In our quest for management innovations for women with dysfunctional bleeding, we should decide whether the new technique is better than the gold standard, hysterectomy. As hysterectomy can be vaginal, laparoscopic with vaginal assistance, totally laparoscopic, or abdominal, one cannot just use the word “hysterectomy”, one must specify. Studies reveal that the vaginal approach is superior.2,5

David H Eizenberg

Martha Hickey,* Cynthia M Farquhar† * Associate Professor of Obstetrics and Gynaecology, University of Western Australia, King Edward Memorial Hospital, 374 Bagot Road, Subiaco, WA 6008; † Associate Professor in Reproductive Medicine, National Women's Hospital, University of Auckland, Auckland, New Zealand. mhickeyATobsgyn.uwa.edu.au In reply: Eizenberg is correct in stating that the levonorgestrel-releasing intrauterine system Mirena is currently licensed as a contraceptive in Australia and not explicitly for treatment of menstrual disorders. He is also correct in stating that vaginal hysterectomy would be a management option for Cases 1 and 2 in our article.1 However, the purpose of our article was to explore newer options in management of menstrual disorders. This does not mean that “traditional” therapies such as hysterectomy are to be overlooked or superseded, and we did not attempt to compare the new therapies with hysterectomy. Dysfunctional uterine bleeding, although disruptive, is a benign condition, and treatment is symptomatic. We believe that women should be aware of all available therapeutic options, including hysterectomy, so that they can reach an informed decision.

Martha Hickey · Cynthia M Farquhar

Saul Wiener Allergist, Royal Melbourne Hospital, 46 Balaclava Road, East St Kilda, VIC 3183. To the Editor: In their study on the effectiveness of antivenom for redback spider bite, Isbister and Gray cast doubt on the current method of administering antivenom intramuscularly.1 Any study on the outcome of treating bites by venomous animals is limited by factors beyond the control of the investigator. These include the variability of the venom content in the animal’s venom apparatus, uncertainty regarding how much and where venom has been injected, and the delay before treatment. Between 1955 and 1957, I dissected the venom glands of 590 redback spiders for the production of antivenom.2 The yield of freeze dried venom per spider varied from 0.08 mg to 0.32 mg. Based on these findings, and to allow for dilution of antivenom by body fluids, “it was considered that 500 units of antivenene would constitute a suitable initial dose for the treatment of a bite by L. hasseltii”.3 This amount of antivenom will neutralise 5 mg of venom in vitro, and the antivenom is still issued in this strength by CSL Ltd. No fatalities have occurred from redback spider bite since antivenom became available in 1956,4 and reports from doctors have confirmed its efficacy and safety.5 If symptoms persist after the initial dose, or if diagnosis has been delayed, the initial dose of 500 units may have to be repeated. As Banham et al have wisely stated “treatment should be titrated against response”.6 Because of the risk of anaphylaxis, intramuscular injection, which has stood the test of time, is safer than the intravenous route.

Saul Wiener

Geoffrey K Isbister Clinical Envenoming Research Group, University of Newcastle, Newcastle Mater Misericordiae Hospital, Locked Bag 7, Hunter Region Mail Centre, NSW 2310 gsbiteATferntree.com In reply: We thank Wiener for his comments on our study. Although we challenge the use of intramuscular redback spider antivenom (RBS AV) in the article, we only suggested that the use of intramuscular antivenom needs review and that randomised controlled trials comparing intravenous and intramuscular RBS AV should be undertaken. Two such trials, in Western Australia and Newcastle, are currently in progress. There are no pharmacokinetic studies of RBS AV, but studies of other antivenoms suggest that the intramuscular route is less effective.1 In Tunisia, the intramuscular use of scorpion antivenom, which is also an F(ab')2 antivenom, similar to RBS AV, has been questioned for similar reasons.2,3 Studies in a rabbit model demonstrated that intramuscular antivenom induced only partial and delayed neutralisation of circulating toxins.3 More importantly, in a study of scorpion stings of children, the intramuscular administration of antivenom had far less effect on plasma venom concentrations and patient recovery times.2 We do not dispute that repeated doses of antivenom may be required, but the implication that only an initial dose was used in our study is incorrect. Half of the treated patients required repeat doses (6 ampoules in one patient). In a recent series of four patients with redback spider bites, intramuscular antivenom was ineffective, even though three patients received two or three ampoules. Subsequent intravenous antivenom was effective in all cases.4 There is no evidence that appropriately administered intravenous RBS AV (diluted in 200 mL of normal saline, over 20–30 minutes) is less safe than intramuscular antivenom. There is insufficient reason to prevent the use of intravenous antivenom if it is shown to be more effective than intramuscular antivenom. Although it is too early to change recommendations for the administration of RBS AV, it is essential that controlled trials be done.

Geoffrey K Isbister

John Boyages Executive Director, New South Wales Breast Cancer Institute, PO Box 143, Westmead, NSW 2145. johnbATbci.org.au To the Editor: I read with interest the position paper on breast self-examination by Crossing and Manaszewicz.1 I would like to point out an error of fact. The New South Wales Breast Cancer Institute (NSW BCI) has been promoting breast self-examination for many years. As a practising clinician, every month I see several women who have found small breast cancers using instructions from an old New Idea shower card or similar information. The position of the NSW BCI, which is stated clearly on our website, is as follows: Women should consider an annual breast examination by their general practitioner, particularly when they attend for a Pap test or a blood pressure check. Mammography should be performed at least every 2 years, particularly for women over 50 years, and earlier for women with a family history of breast cancer. Women should practise regular breast self-examination (BSE). Information about BSE can be obtained from GPs and the BCI has produced a fact sheet (www.bci.org.au/public/guides/g8bse.htm). BSE costs nothing and, in our opinion, does more good than harm. However, BSE should be combined with regular mammography and an examination by a GP. For a woman with a family history of breast cancer, or who has been diagnosed with breast cancer, BSE can be helpful in finding disease. Mammography is only about 95% reliable. BSE complements mammography. Certain types of breast cancer are often difficult to diagnose with mammography, for example “lobular” cancer, and BSE may help in finding such cancers. No evidence has been published that would justify a change in this position.

John Boyages

James E Fielding,* Heath Kelly† * Epidemiology Registrar, Communicable Disease Control Branch, Department of Human Services, PO Box 6, Rundle Mall, Adelaide, SA 5000; † Head, Epidemiology and Surveillance Division, Victorian Infectious Diseases Reference Laboratory, North Melbourne, VIC. james.fieldingATdhs.sa.gov.au To the Editor: In addition to a complicated ethical approval process, new privacy laws have presented challenges for multicentre research studies.1 In Victoria, an amendment to the Guardianship and Administration Act 1986 came into effect on 1 January 2003. We wish to highlight its unanticipated ramifications. We proposed to conduct a pilot study on the feasibility of ascertaining cases of Murray Valley encephalitis (MVE) in Victorian hospitals. Currently, there is no routine human surveillance for MVE, and we intended to perform diagnostic tests for several encephalitis aetiological agents on routinely collected samples. A study protocol was developed and submitted in November 2002 to five Human Research Ethics Committees (HRECs), one at the Department of Human Services and four at hospitals where the study was to be conducted. The case definition for encephalitis included the criterion that the patient had an “altered conscious state”, and could not therefore give informed consent. Informed consent was to be provided by the patient’s next-of-kin, but, in late December, an HREC representative alerted us to an imminent amendment to the Act which stipulated that only a guardian appointed by the Victorian Civil and Administrative Tribunal (VCAT) could provide consent to participate in “any procedure carried out for the purposes of medical research” on behalf of a disabled patient (in this instance, a patient with an altered conscious state). The Act does not further define medical research. Surveillance involves no intervention, and it is unclear to us (and some ethics committees) whether surveillance was considered a “procedure”. We indicated our uncertainty in a letter to VCAT in January 2003. If an application to VCAT were required for each patient we wished to enrol, then the study became unworkable. Under legislative requirements, VCAT is only obliged to “commence to hear” an application within 30 days of its receipt, which would prevent surveillance being conducted in a timely manner. Awareness of the legislative amendment differed between HRECs. In December 2002, two committees gave full approval for the study without reference to the amendment, while the remainder gave conditional approval, subject to complying with the amended Act. VCAT wrote to HRECs in February 2003 to clarify the amendment, and directly indicated to us that it did not apply to our proposed study. In May, despite the correspondence from VCAT, one HREC reaffirmed its position that applications must be made to VCAT for consent for studies such as this one. Despite attempts at clarification, a legislative amendment in Victoria has created ongoing confusion about obtaining consent on behalf of disabled patients. Researchers planning studies involving invasive procedures (eg, blood chemistry or seroprevalence studies) need to be aware of the amendment’s potential impact. Differences in interpretation of the amendment by the tribunal and various ethics committees highlight the need for further clarification of the Act, as well as for centralised and consistent assessment of HREC applications.

James E Fielding · Heath Kelly

Martin B Van Der Weyden Editor, Medical Journal of Australia, Locked Bag 3030, Strawberry Hills, NSW 2012. editorialATampco.com.au Comment: Fielding and Heath raise two issues. The first is the increasing barriers to the conduct of research as the law and Human Research Ethics Committees (HRECs) quite rightly ensure the safety of participants in human research. In the words of Cicero, salus populi suprema est lex (“the welfare of the people is the highest law”),1 but the law is not immutable. The confusion uncovered by Fielding and Heath over the implications of the amendment to the Guardianship and Administration Act 1986 may prompt legislators to re-examine the purpose of the Act in the context of research involving patients with “altered conscious state”. The second issue raised is more general. The plurality of HRECs’ interpretations of the amendment may be difficult to fathom by ordered scientific minds: data are data, so why the differences in HRECs’ opinions? These frustrating differences are the bane of researchers involved in multicentre research.2,3 The 1999 National statement on ethical conduct in research involving humans4 empowers HRECs to minimise duplication and allows for ethical and scientific assessments made by one HREC to be accepted by others.5 Nevertheless, HRECs value their independence and are unlikely to relinquish it to others easily.6 Various states are considering the feasibility of centralised ethical bodies,5 but bureaucracy moves cautiously and change is always slow.

Martin B Van Der Weyden

Steve Lontos,* Robert M Jones,† Peter W Angus,‡ Paul J Gow§ * Liver Transplant Registrar, † Director, Liver Transplant Unit, ‡ Director, Department of Gastroenterology, § Gastroenterologist, Austin and Repatriation Medical Centre, Studley Road, Heidelberg, VIC 3084 paul.gowATarmc.org.au To the Editor: We wish to report a case of acute liver failure associated with the use of a herbal preparation that contained several ingredients, including Cimicifuga racemosa (black cohosh). In January 2003, a 52-year-old woman was referred to our unit with acute liver failure. She had taken a herbal preparation for three months (for severe tinnitus), but ceased four weeks before admission. The preparation was made and provided by a pharmacist. The preparation was supplied in a 200 mL bottle and contained a mixture of the fluid extracts of Nepeta hederacea (ground ivy) 80 mL, Hydrastis canadensis (golden seal) 20 mL, Ginkgo biloba (ginkgo) 40 mL, Avena sativa (oats seed) 40 mL and Cimicifuga racemosa (black cohosh) 20 mL. According to the information supplied by the pharmacist, one gram of herb was contained in each 1 mL of extract, with the exception of golden seal, for which 0.5 g of herb was contained in each millilitre. The oats seed fluid extract was supplied by Southern Cross Herbal School (Gosford, NSW), and all other fluid extracts were supplied by the Herbal Extract Company of Australia (Sydney, NSW). The patient took a total of 600 mL over the 3-month period (7.5 mL bd orally as required). Before developing symptoms of liver failure, the patient had taken no other medications and had no risk factors for the acquisition of viral hepatitis. On arrival, she was deeply jaundiced but not encephalopathic. Liver span was reduced and there were no signs of chronic liver disease. The international normalised ratio was 3.0 (normal, 1.0–1.2), and she had serum concentrations of albumin, 26 g/L (normal, 35–50 g/L); bilirubin, 368 μmol/L (normal, < 18 μmol/L); alkaline phosphatase, 230 U/L (normal, 35–104 U/L); alanine aminotransferase, 1380 U/L (normal, < 55 U/L); and g glutamyl-transpeptidase, 134 U/L (normal, < 45 U/L). Extensive investigation excluded other recognised causes of acute liver failure. Her condition deteriorated over the following week, with the development of hepatic encephalopathy and hepatorenal failure. She underwent liver transplantation in early February 2003, and had an uneventful postoperative course. Examination of the explanted liver revealed massive hepatic necrosis. Following transplantation, the pharmacist supplied samples of the individual extracts to the Therapeutic Goods Administration (Canberra) for analysis. The analysis revealed no undeclared pharmaceutical drugs. Assay of the individual extracts of golden seal, ginkgo and black cohosh revealed the listed ingredients to be present. The presence of ground ivy and oats seed in the extracts has not yet been confirmed owing to the lack of a suitable reference standard. It is not possible to determine the individual ingredient, or mixture of ingredients, that resulted in acute liver failure in this patient. However, this is the third case of acute liver failure associated with black cohosh ingestion to be reported recently in Australia.1 In this instance, liver failure progressed despite cessation of the herbal therapy, and transplantation was required, suggesting that a process of irreversible liver injury had been initiated before treatment was ceased. It should be noted that ground ivy contains pulegone, a known hepatotoxin. However, the concentration of pulegone in ground ivy is accepted to be vastly less than in pennyroyal, where pulegone-induced hepatotoxicity has been reported.2 To our knowledge, there are no reports of golden seal, oats seed or ginkgo causing hepatotoxicity. The popularity of herbal therapies is due in part to their perceived lack of side effects. It is important for the medical and broader community to be aware of the potential toxicity of these preparations. In any patient presenting with unexplained hepatitis it is essential to determine if there has been exposure to herbal therapies, since early cessation of treatment may be life saving.

Steve Lontos · Robert M Jones · Peter W Angus · Paul J Gow

Michael D Coory Medical Epidemiologist, Queensland Health, GPO Box 48, Brisbane, QLD 4001. michael_cooryAThealth.qld.gov.au To the Editor: The randomised controlled trial associated with the Women’s Health Initiative (WHI) found that long-term hormone replacement therapy (HRT) with combined oestrogen–progestin causes net harm.1 Both the article by Baber and colleagues on HRT2 and a previous editorial by Patel and colleagues3 imply that the method used to calculate the confidence intervals in the WHI report is questionable. Baber et al suggest that “a trial such as this, with multiple endpoints, should use adjusted rather than nominal confidence intervals to test individual endpoints for significance”.2 It is important that this issue is clarified. In the WHI report in JAMA, Table 2 shows both nominal and adjusted confidence intervals for the primary and secondary outcomes.1 Nominal confidence intervals are appropriate for the preselected primary outcomes of the trial — breast cancer, coronary heart disease and the composite global-index score.4 Confidence intervals adjusted for multiple comparisons are possibly appropriate for the multiple secondary endpoints in the study, but are not advocated by all statisticians.5 In any case, the decision of Baber and colleagues to concentrate on adjusted confidence intervals for the preselected primary outcomes is not valid.4 The purpose of confidence intervals is to assess the effects of random variation or chance. It is not sensible to suggest that the extra harm that occurred in the combined HRT arm of the WHI study could be due to chance. Moreover, 42% of women in the HRT group stopped taking the drug, and 11% of women in the placebo group started taking it.1 Therefore, the reported findings of the intention-to-treat analysis underestimated the true harm to individual women taking long-term HRT. Also, if duration of treatment is important (as appears the case with breast cancer risk), and because compliance decreased over time, 5-year results underestimated longer-term treatment harm.4 The aim of the WHI trial was to assess whether long-term HRT is a useful preventive intervention for postmenopausal women. It did not assess the short-term use of HRT to relieve severe hot flushes. As Sackett points out, curative and preventive medicine are absolutely and fundamentally different in their obligations and implied promises to the individuals whose lives they hope to modify.6 As a long-term preventive intervention, HRT causes more harm than good. Although the absolute risks were small, millions of women were prescribed this treatment worldwide, causing harm to thousands. Billions of dollars were spent on an ineffective preventive intervention.6 The thousands of Australian women who stopped taking HRT on learning the results of the WHI trial made a sensible decision.

Michael D Coory

Rodney J Baber,* Justine L O’Hara,† Frances M Boyle‡ * Clinical Senior Lecturer, Department of Obstetrics and Gynaecology, University of Sydney, NSW, 2006; † Medical Student, ‡ Oncologist, Royal North Shore Hospital, Sydney, NSW. rbaberATmail.usyd.edu.au In reply: We acknowledge that not all statisticians agree on the place of adjusted confidence intervals. However, we and others1,2 believe they represent a conservative choice for secondary endpoints in a study with multiple endpoints, such as the WHI trial. Results of recent randomised controlled trials of hormone replacement therapy (HRT) and cardiovascular disease certainly support the notion that HRT confers no protection. However, any real harm of HRT must be questionable in light of the rapid review by Beral and colleagues, which, also using nominal confidence intervals, showed no change in relative risk for HRT users.3 We are surprised that, having emphasised the importance of nominal confidence intervals for primary endpoints, Coory did not mention that the breast cancer risk in the WHI report was not statistically significant using either nominal or adjusted CIs, or that the global index used was a non-validated instrument designed for and used only in the WHI study.4 Intention-to-treat analysis is used to avoid overestimates of both harm and benefit. While drop-in and drop-out rates (equal in both arms) may have led to underestimates of harm from HRT, they may also have led to underestimates of benefit, with no net change to risk–benefit assessment. The aim of the WHI trial was to assess the benefit or otherwise of long-term HRT on disease processes in otherwise healthy women. There seems little doubt that in the group of older, overweight, somewhat hypertensive, women enrolled in this trial the use of HRT was not beneficial. The aim of our article was to assess the case for and against HRT use.5 In reaching our conclusions, we drew on a broad range of published data, including, but not confined to, the WHI data. Our conclusions make it clear that we believe the use of HRT is primarily for short-term relief of symptoms during the menopause transition. However, we sought to defend the right of a small number of women to choose to continue HRT for long-term improvement of quality of life and symptom relief after appropriate, balanced, individualised counselling about the risks and benefits of such a decision. We do not agree with Coory’s final comment. The thousands of Australian women who stopped taking HRT on learning the results of the WHI trial did so in fear and ignorance in an environment where their physicians were unable to offer balanced counsel — hardly a formula for good medicine.

Rodney J Baber · Justine L O’Hara · Frances M Boyle

Donna B Mak,* Alastair MacKendrick,† Max K Bulsara,‡ Sharon Weeks,§ Lewis Leidwinger,¶ Harvey Coates,** Francis J Lannigan,** Deborah Lehmann†† * Public Health Physician, ¶ Audiologist, Kimberley Public Health Unit, Derby, WA; † Ear, Nose and Throat Surgeon, Southern Corridor ENT Services, South Fremantle, WA; ‡ Biostatistician, Biostatistical Consulting Service, School of Population Health, University of Western Australia, Crawley, WA; § Audiologist, Disability Services Commission, West Perth, WA; ** Ear, Nose and Throat Surgeon, Department of Otorhinolaryngology – Head and Neck Surgery, Princess Margaret Hospital for Children, Subiaco, WA; †† Senior Research Fellow, Centre for Child Health Research, University of Western Australia, Telethon Institute for Child Health Research, Subiaco, WA. Correspondence: Dr Donna B Mak, 189 Royal Street, East Perth, WA 6000. makhoATbigpond.com To the Editor: Chronic suppurative otitis media is very common among Australian Aboriginal children, resulting in hearing loss and educational and social disadvantage.1 Reconstructive middle-ear surgery has been part of the accepted treatment for decades. However, there are no publications about long-term outcomes in Aboriginal populations.2 We report here the results of a study of long-term postoperative outcomes in Aboriginal children following reconstructive middle-ear surgery. We studied all Aboriginal children aged ≤ 15 years who underwent middle-ear surgery for a tympanic membrane perforation (excluding cholesteatoma) in the Kimberley region of Western Australia between 1 October 1986 and 31 December 1995. Data had been collected prospectively during a previous study, and long-term follow-up was undertaken as part of a recent study of middle-ear surgery outcomes.2,3 Ethical approval was obtained from the WA Aboriginal Health Information and Ethics Committee. The study population consisted of 93 children (57 girls, 36 boys), aged 5–15 years (mean, 10 years; median, 10 years) at the time of operation. Preoperative air–bone gap (ABG) measurements ranged from 8.75 to 58.75 dB (mean, 36.7 dB; median, 36.25 dB). The operations were performed by nine surgeons at three hospitals and included tympanoplasty using temporalis fascia (73%), dura (13%), and other graft materials (8%), and mastoidectomy (6%). Sixty-four children (69%) underwent early postoperative review (median follow-up interval, 11 months) and 73 children (78%) underwent late postoperative review (median follow-up interval, 103 months). More of the patients had a late review because, at the time, additional resources were available to actively locate the patients for follow-up. At late postoperative review, 56/93 (60%) patients had a successful outcome (intact tympanic membrane and normal hearing) and 17/93 (18%) did not (20/93 [22%] did not undergo late postoperative review). Of the 32 patients who had a successful outcome at the early postoperative review (median follow-up interval, 5 months), 26 (81%) underwent late postoperative review; 24/26 (92%) still had an intact tympanic membrane and ABG ≤ 25 dB at late postoperative review (median follow-up interval, 109 months) (Box). These findings indicate that successful tympanic membrane closure with hearing improvement after middle-ear surgery in Aboriginal children is probably longlasting. The major limitation of our study is the absence of clinical information in the time period (mean, 8 years) between the early and late postoperative reviews. An unknown (but likely to be small) number of patients may have had further operations and/or conservative management, which may have influenced their ear health status at late postoperative review. Collection of these data would have been extremely difficult given the nomadic lifestyle of many patients and the logistical realities of remote-area healthcare. Our findings support the current recommendation of the Office of Aboriginal and Torres Strait Islander Health that Aboriginal children should be offered tympanoplasty if conservative management of chronic suppurative otitis media is unsuccessful.4 Postoperative review status of 93 Aboriginal children who underwent middle-ear surgery for a tympanic membrane (TM) perforation* in the Kimberley region of Western Australia between 1 October 1986 and 31 December 1995† * Excluding cholesteatoma. † If a patient had more than one operation, the first ear operated on during this time period was included in the analysis. If a patient had operations on both ears on the same date, the ear with the largest preoperative hearing loss was included. If hearing loss was the same on both sides, the right ear was chosen.

Donna B Mak · Alastair MacKendrick · Max K Bulsara · Sharon Weeks · Lewis Leidwinger · Harvey Coates · Francis J Lannigan · Deborah Lehmann

Rosie G Scott,* John T Edwards,† Richard M Mendelson,‡ Geoffrey M Forbes§ * Research Fellow, ‡ Radiologist, Department of Diagnostic and Interventional Radiology; † Gastroenterologist, § Gastroenterologist (corresponding author), Department of Gastroenterology and Hepatology; Royal Perth Hospital, PO Box X2213 GPO, Perth, WA 6000 geoff.forbesAThealth.wa.gov.au To the Editor: The burden of colorectal cancer can be minimised, firstly, by early and appropriate investigation of symptoms; secondly, by screening those at higher-than-average risk without symptoms; and thirdly, by community-based screening of asymptomatic people aged over 50 years who are at average risk. Major screening programs using faecal-occult-blood testing (FOBT)1-3 or flexible sigmoidoscopy4 have not necessarily made this differentiation. These tests lack the sensitivity of colonoscopy, which is generally indicated for those with symptoms or a strong family history of colorectal cancer. In our recent community-based screening program in which we used virtual colonoscopy, we excluded those at higher than average risk for colon cancer (that is, they were symptomatic or had at least one first-degree relative with colon cancer), as our standard of care for these patients is colonoscopy. They were given verbal and written advice to see their general practitioner, with the expectation that most should have colonoscopy. They were followed up an average of 12 months (range, 6–15 months) later, by letter and telephone, to determine the outcome of this advice. Of 2000 participants aged 50–69 years who were offered screening, 90 (4.5%) described having symptoms or a first-degree relative with bowel cancer, but had not undergone investigation. Follow-up information obtained from 71 of these people indicated that 21 had a relevant family history and 50 described recent bowel symptoms. Only 35 (49%) had discussed further investigations with their GPs — 19 (27%) had undergone colonoscopy, and five of these (26%) had advanced colorectal neoplasia (CRN). One had tubular adenoma (> 1 cm), one showed villous architecture, one had intramucosal carcinoma, and two had cancer. Four other participants had had negative results on other investigations. These were FOBT alone in three (two symptomatic, one with family history) and barium enema in one who had bleeding. Common reasons for not consulting their GPs were because of good health (15 participants), resolution of symptoms (12), and perceived lack of need for tests (10). These data have important implications for CRN screening programs, including recently commenced Australian pilot programs (www.cancerscreening.gov.au). Firstly, there is likely to be an improved yield of advanced CRN when a previously uninvestigated high-risk group is identified within a screening program. Secondly, people identified as having higher-than-average risk for CRN need special attention to ensure there is adherence to advice on appropriate follow-up. Thirdly, procedures are required to ensure colonoscopy is appropriately undertaken when participants do consult their GPs. Accordingly, rather than adopting an exclusion policy within a screening program based on FOBT or flexible sigmoidoscopy, we believe it is appropriate that people at greater risk for CRN are identified and offered colonoscopy within that program.

Rosie G Scott · John T Edwards · Richard M Mendelson · Geoffrey M Forbes

Gavin Turrell,* Brian F Oldenburg,† Elizabeth Harris,‡ Damien J Jolley,§ Merel L Kimman¶ * Senior Research Fellow, † Head of School, ¶ Student, School of Public Health, Queensland University of Technology, Victoria Park Road, Kelvin Grove, QLD 4059; ‡ Director, South West Sydney Area Health Service, Centre for Health Equity Research, Training and Evaluation, Liverpool, NSW; § Director, School of Health Sciences, Biostatistics and Epidemiology Unit, Deakin University, Burwood, VIC. g.turrellATqut.edu.au To the Editor: Studies investigating the relationship between socioeconomic status (SES) and use of healthcare services suggest that, in metropolitan regions, low-SES groups consult general practitioners more frequently than high-SES groups.1 The primary reason is their poorer health and hence greater medical need (however, distributional, operational and financial factors associated with the provision of general practice services are also important). Is a similar relationship found between SES and GP use in non-metropolitan areas? We investigated this issue using data from the Social health atlas of Australia project.2 We defined “GP use” as unreferred services3 provided by general and vocationally registered practitioners (not specialist medical practitioners), delivered at a surgery or clinic, a patient’s home, or an institution such as a hostel or nursing home. Specifically, 952 statistical local areas (SLAs), comprising 98.6% of all SLAs for the six Australian states, were classified into four geographic remoteness categories (see Box) using the Accessibility/Remoteness Index of Australia (ARIA).4 Within each ARIA category, we grouped SLAs into tertiles of socioeconomic disadvantage based on their Australian Bureau of Statistics’ Socio-Economic Indexes for Areas (SEIFA) score. We then compared the average rates of GP use between tertiles for the 2-year period 1996–1997. Our analysis included a measure of the number of full-time equivalent (FTE) GPs per 10 000 population in each SLA as a test of equity: similar or higher rates of GP use in disadvantaged SLAs independent of GP availability suggest equity of access. In areas classified as “highly accessible”, rates of GP use were significantly (10%) higher in disadvantaged SLAs after adjusting for GP availability (Box). The reverse was found in “remote/very remote” areas, where rates of GP use were about 36% lower in disadvantaged SLAs. Also, the strength of the relationship between GP availability and GP use differed across the ARIA categories. In “highly accessible” areas, a unit increase in the number of FTE GPs per 10 000 population was associated with a 1% increase in GP use, whereas in “remote/very remote” areas it was associated with a 15% increase (data not shown). This suggests that disadvantaged groups in rural and remote areas experience disproportionate difficulty accessing GP services. These areas are underserved by GPs, who charge more for their services and are less likely to bulk-bill.5 It seems that in metropolitan regions the Medicare principle of equity of access to GP services is being realised (ie, people with higher levels of morbidity are making greater use of GP services), whereas in remote and very remote areas this is not the case. The findings might also reflect the fact that disadvantaged groups (especially in rural and remote areas) make greater use of emergency departments of local hospitals or other community-based or primary care outreach services — these services are not covered by Medicare and, therefore, are not taken into account in the rates of GP use presented here. Association between socioeconomic disadvantage and use of general practitioners within ARIA* categories† * ARIA (Accessibility/Remoteness Index of Australia) categories:4 Highly accessible: areas with relatively unrestricted access to a wide range of goods and services and opportunities for social interaction. Accessible: areas with some restrictions to accessibility of some goods, services and opportunities for social interaction. Moderately accessible: areas with significantly restricted accessibility of goods, services and opportunities for social interaction. Remote/very remote: areas with very restricted or very little accessibility of goods, services and opportunities for social interaction. † Relationship between area disadvantage and GP use is adjusted for number of full-time equivalent GPs per 10 000 population. ‡ Each tertile comprises approximately a third of the statistical local areas (SLAs) in the six Australian states. The high and low tertiles comprise the 33% least and most socioeconomically disadvantaged SLAs, respectively.

Gavin Turrell · Brian F Oldenburg · Elizabeth Harris · Damien J Jolley · Merel L Kimman

Lynne Hillier,* Richard De Visser,† Anne M Kavanagh,‡ Ruth P McNair§ *,† Research Fellows, ‡ Senior Research Fellow, Australian Research Centre in Sex Health and Society, La Trobe University, Level 1, 215 Franklin Street, Melbourne, VIC 3000; § Senior Lecturer, Department of General Practice, Melbourne University, Carlton, VIC. l.hillierATlatrobe.edu.au To the Editor: Studies of non-representative population samples show that recreational drug use is more prevalent among non-heterosexual women than heterosexual women.1 The Australian Longitudinal Study of Women’s Health2 allowed an examination of the links between sexuality and recreational drug use in a representative sample of 9260 women aged 22–27 years in 2000. Respondents reported their history of tobacco, alcohol and illicit drug use. Reported frequency and volume of alcohol consumption were recorded according to National Health and Medical Research Council guidelines.3 Use of illicit drugs in the last year was dichotomised between marijuana and other illicit drugs (see Box). Respondents also indicated whether they had ever injected illicit drugs. Analyses compared exclusively heterosexual women with all other women. Data were weighted to correct for over-sampling in non-metropolitan areas. Odds ratios were adjusted for age, region of residence, and father’s occupation (as a measure of social class). Younger women were significantly more likely to report risky drinking and illicit drug use. Women from urban areas were significantly more likely to be non-heterosexual and to use illicit drugs, but less likely to report risky levels of alcohol consumption. Women whose fathers were professionals or managers were significantly more likely to be non-heterosexual and more likely to use illicit drugs, but less likely to smoke or report risky drinking. Details are available from the authors. Non-heterosexual women were significantly more likely than heterosexual women to have ever smoked, to be current smokers, to report risky levels of alcohol consumption, to have used marijuana and other illicit drugs in the last year, and to have ever injected drugs (Box). Although these relative differences are important, so too are the absolute values — 45.6% of non-heterosexual women were smokers, and 45.6% reported alcohol consumption of concern. In the last year, 58.2% used marijuana and 40.7% used other illicit drugs. One in 10 had ever injected illicit drugs. Although women are generally less likely than men to use drugs, and may not be a high-priority target for drug education, non-heterosexual young women’s rates of illicit drug use are at least as high as those of young men.4 Higher levels of drug use among young non-heterosexual women may be the result of individual experiences of homophobic discrimination, where drugs are used as an — albeit, short lived — panacea.1 Greater drug use may also be the result of normalisation of recreational drug use within lesbian communities.5 There is a need for specific interventions in young non-heterosexual women, and for further research to determine the reasons for their high levels of recreational drug use. Frequencies and adjusted odds ratios for drug use among 9260 heterosexual and non-heterosexual Australian women aged 22–27 years, 2000 Drug use Exclusively heterosexual Bisexual and lesbian Adjusted odds ratio* (95% CI) Smoking status (n = 8284) (n = 755) Never smoked 60.8% 37.0% 1.00 Former smoker 14.2% 17.4% 2.15 (1.65–2.79) Current smoker 25.0% 45.6% 3.18 (2.61–3.89) Alcohol consumption† (n = 8419) (n = 796) No risk 36.7% 23.9% 1.00 Low risk (no bingeing) 31.5% 30.6% 1.33 (1.05–1.69) Low risk (with bingeing) 27.9% 38.6% 2.01 (1.60–2.52) Risky 3.9% 7.0% 2.50 (1.68–3.72) Illicit drugs (n = 8409) (n = 797) Marijuana (in the last year) 21.5% 58.2% 4.68 (3.91–5.61) Other illicit drugs‡ (in the last year) 10.2% 40.7% 5.50 (4.51–6.71) Injected drugs (ever) 1.2% 10.8% 12.26 (8.53–17.63) * Adjusted for age, region of residence, and father’s occupation. † According to National Health and Medical Research Council guidelines.3 ‡ Amphetamines, LSD (d-lysergic acid diethylamide), ecstasy/designer drugs, tranquillisers, natural hallucinogens, cocaine, inhalants, heroin, barbiturates.

Lynne Hillier · Richard De Visser · Anne M Kavanagh · Ruth P McNair

Andrew B Black,* Sam F Berkovic† * Neurologist, The Queen Elizabeth Hospital, Woodville, SA; and Chair, Driving Committee, Epilepsy Society of Australia. † Neurologist, Austin and Repatriation Medical Centre, West Heidelberg, VIC; and President, Epilepsy Society of Australia. Correspondence: Dr A B Black, Ashford Specialist Centre, 57–59 Anzac Highway, Ashford, SA 5035. abblackATchariot.net.au To the Editor: Seizure disorders are often the most scrutinised medical conditions in relation to road accidents.1 Epileptologists internationally have reached some consensus on the role best played by treating doctors: ensuring patients receive proper medical care; advising on assessed risk and its minimisation; and reporting (if necessary, without patient consent) when a patient becomes a risk yet continues to drive.2 In a recent editorial on sleep disorders and driving,3 McEvoy also emphasises the essential role of first establishing the therapeutic relationship, and refers to the impending release by the National Road Transport Commission of new medical standards for all vehicle types.4 Australian neurologists and the Epilepsy Society of Australia find that the new guidelines are imprecise in defining the role played by doctors and Driver Licensing Authorities (DLAs), and are excessively detailed with cumbersome processes that are open to confusion. The instructions for using four separate forms (3.3) are complex and imprecise, giving no indication about discretion in their use or non-use. Moreover, it is not the role of doctors to define specific restrictions for holders of conditional licences (3.3.1), but that of the DLA. Demands on doctors for surveillance and enforcement are excessive, and by interfering with the maintenance of proper rapport may prove counter-productive. The roles for consultants are not clearly defined. A more desirable model is one in which the DLA takes responsibility for all legally enforceable decisions and does not expect treating doctors to decide on fitness-to-drive. A treating doctor may provide factual information, but is not expected to give an opinion on licensing questions. This model, used in the United Kingdom,5 is simple, well understood and respected. The DLA there obtains independent medical advice in deciding borderline cases, an optional mechanism given little attention in the Australian review. Doctors in the UK are well aware of their common law duty to report patients if their actions are endangering. We are drifting away from this simpler and ethically and medicolegally more satisfactory model at our peril. We should re-engage our DLA colleagues to establish a more effective relationship, in which they ensure their licence holders are well informed of their obligations, while we provide the expert care and management of our patients which will best encourage a safer driving environment.

Andrew B Black · Sam F Berkovic

Keith V Woollard Cardiologist, 34 Murdoch Drive, Murdoch, WA 6015. KeithWoollardATwacardiology.com.au To the Editor: The recent review of digoxin by Campbell and MacDonald1 pointed out that a serum digoxin level of over 1.0 ng/mL is associated with excess mortality. Indeed, higher blood levels (≥ 1.2 ng/mL) are associated with higher crude rates for all-cause hospitalisation, and for increased hospitalisation for worsening heart failure or suspected digoxin toxicity.2 The post hoc analysis of the DIG trial2 suggests that the optimal range is 0.5–0.8 ng/mL. I recently surveyed 31 private pathology laboratories across Australia to determine their recommendations about the therapeutic range of serum levels of digoxin. In summary, their recommendations ranged from a lower limit between 0.5 ng/mL and 1.0 ng/mL, and an upper limit between 1.6 ng/mL and 2.1 ng/mL. Twenty-six of the 31 suggested that values below 0.8 ng/mL were subtherapeutic. It is likely that many doctors will heed such advice and inappropriately increase the dose of digoxin in patients being treated for heart failure. It is possible that adverse effects will flow from current laboratory industry recommendations, and these should be revised.

Keith V Woollard

Abdullah Demirkol,* Jan Ritchie,† Pippa Craig,‡ on behalf of nine co-researching patients * PhD Candidate, † Associate Professor in Public Health, ‡ Conjoint Lecturer, School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW 2051 j.ritchieATunsw.edu.au To the Editor: Oldroyd et al provide some revealing views of general practitioners on the many difficulties and few rewards arising from their care of chronic disease patients.1 As co-researchers in a participatory action research inquiry, exploring how nine of us living with Type 2 diabetes can better manage our condition, we read the article with interest and wish to give our perspective, as patients, on the issues addressed. Oldroyd et al report that many GPs describe chronic disease management as a “burden”. We are only too aware of this negative response when we present with our chronic conditions. GPs are usually our first, and often only, regular contact with the healthcare system. Although we would like to rely heavily on them, we rarely find they have enough time for us. The standard consultation is barely long enough for renewal of our prescriptions. Yet, for a couple of us who have recently wanted extended assistance, the situation has been exacerbated when our GPs have resisted specialist referral, on the assumption that their care is sufficient. The article reports the conflict felt by many GPs concerning implementation of clinical management guidelines, many of which they felt were not feasible in their everyday practice. Again, we share the discomfort this brings when we are informed of the guidelines, yet know that they do not fit with our own personal situation. We would dearly love more collaboration and negotiation in developing workable solutions best suited to our own unique circumstances. As one of us states, “none of those clinical, scientific studies can possibly be as long, complex and complicated as real life”. We believe we have accumulated a considerable amount of experience and knowledge about living with diabetes, and feel disappointed that our experience is not considered of value. It is apparent that we share the same goals as GPs in seeking effective chronic disease management, but the different knowledge bases and perspectives of doctors and patients have not coalesced. Involvement in this current participatory inquiry has given us the confidence to speak out and to propose that, as patients, we should become legitimate members of the treatment team. We await an invitation to be part of the process in implementing initiatives.

Abdullah Demirkol · Jan Ritchie · Pippa Craig

Christopher M Doran,* Julia E Fawcett,† Anthony P Shakeshaft,‡ Marian D Shanahan,§ Richard P Mattick¶ * Health Economist, † Research Officer, ‡ NHMRC Fellow and Senior Investigator, § Health Economist, ¶ Director, National Drug and Alcohol Research Centre, University of New South Wales, NSW 2052. C. DoranATunsw.edu.au To the Editor: An estimated 512 935 Australian adults satisfy criteria for alcohol dependence (3.5% of the population aged 18 years and over).1 Pharmacotherapy for this condition typically comprises a benzodiazepine, such as diazepam, for withdrawal and disulfiram for relapse prevention.2 Acamprosate and naltrexone have also recently become available for treating alcohol dependence in Australia, but little is known about their uptake or cost. One indicator of uptake is the proportion of alcohol-dependent individuals who have a script filled. Based on the number of scripts for these drugs filled in Australia in 2001, and assuming 50% compliance with the recommended treatment periods, we estimated that 4602 people took acamprosate and 8899 naltrexone in that year (Box). This is equivalent to a maximum of about 3% of alcohol-dependent individuals taking either drug (13 501 individuals using either drug/512 935 alcohol-dependent individuals). We also estimated the cost of visits to medical practitioners for scripts for these drugs, assuming that most were written by general practitioners, and the costs of the drugs themselves to the Australian government and to individual patients (Box). Total treatment and medication cost of the two drugs in 2001 was $7 420 741. These estimates are based on assumptions about the relevant population sub-group (age >18 years), rate of compliance with the recommended regimen (50%), source of scripts (GPs), and GP fees (first visit, $25.05; subsequent visits, $11.14). Varying these assumptions makes little difference to the likely uptake of either acamprosate or naltrexone; applying more conservative assumptions suggests that either medication is unlikely to have been used by more than 5% of alcohol-dependent individuals in Australia. Although use of these medications is not necessarily appropriate for all dependent individuals, their low uptake raises serious concerns about why they are being under-utilised: it may be because they are poorly marketed, or it may be that they are of limited effectiveness in Australia outside the context of clinical trials. The latter possibility is exacerbated by the nebulous nature of the comprehensive treatment programs recommended for their use.5 Without methodologically rigorous Australian data, it is difficult to confidently allay such concerns. However, these results indicate a considerable amount of resources are being devoted to acamprosate and naltrexone as treatments for alcohol dependence, with little Australian evidence as to whether this investment represents value for money. Use and cost of new medications for alcohol dependence in Australia in 2001 Acamprosate Naltrexone Number of scripts filled3 27 613 13 349 Estimated number of users* 4602 8899 General practitioner visits Estimated number† 13 807 8899 Estimated cost§ $251 129 $240 794 Medication cost3,5 Cost to government $4 442 204 $2 115 315 Estimated cost to patients¶ $252 407 $118 892 Total cost $4 945 740 $2 475 001 * Number of scripts filled/number of scripts needed for recommended treatment period (12 months for acamprosate and 3 months for naltrexone,4 with each script providing one month’s supply5)/compliance (assumed to be 50%). † Based on 6 visits per year for acamprosate prescription (12 scripts; 1 repeat per script), and 2 visits per year for naltrexone prescription (3 scripts; 1 repeat per script), but assuming 50% compliance with recommended treatment period. § Based on 2001 Medicare rates (85% of MBS code 23 [$25.05] for first visit, and 85% of MBS code 3 [$11.14] for subsequent visits) plus mean patient cost per GP/vocationally registered GP visit for 2001 of $2.62.6 ¶ Taking into account variation in patient Medicare classification (general, concessional or safety net), which varied over the year.3,5

Christopher M Doran · Julia E Fawcett · Anthony P Shakeshaft · Marian D Shanahan · Richard P Mattick

Robert G Moses,* Alison J Webb,† Christine D Comber‡ * Clinical Director, † Nurse, Diabetes Service; ‡ Nurse, Department of Obstetrics and Gynaecology, Illawarra Area Health Service, PO Box W58, Wollongong West, NSW, 2500. mosesrATiahs.nsw.gov.au To the Editor: Gestational diabetes mellitus (GDM) is glucose intolerance of variable severity with onset or first recognition during the current pregnancy.1 GDM is one of the conditions requiring an entry on the New South Wales Midwives Data Form. Effective healthcare planning is dependent on accurate data collection. To our knowledge, the verity of the midwives data with respect to GDM, or indeed other entities, has not been checked for many years. A previous article has demonstrated that the accuracy of GDM data collection is poor, with the incidence of GDM being under-reported.2 Recently, an article from Victoria also showed a recorded rate of GDM about half that of the acknowledged incidence.3 We have recently completed a review of compliance with GDM testing in our area and, knowing the true incidence of GDM, this has allowed us to revisit the accuracy of the data being recorded on the Midwives Data Collection Form. In the city of Wollongong, NSW, with a population of around 280 000 and about 3000 births each year, all deliveries take place at two public hospitals (Wollongong and Shellharbour) and a private hospital (Illawarra Private Hospital). It is the policy of both the Obstetric Department and the Division of General Practice that all pregnant women should be tested for GDM in accord with the ADIPS guidelines.4 All women who delivered at the three hospitals over the 6-month period from January 2002 to June 2002 were identified from the Labour Ward records. A hospital-based delivery is used by 99.3% of women in the area.5 The results of testing for GDM were determined for all of these women. There were 1655 deliveries at the three hospitals over the 6-month period. Seven women with known type 1 or type 2 diabetes were excluded, leaving 1648 women whose data could be examined. Women were considered to have been tested for GDM (n = 1518) if they had had either a glucose tolerance test (n = 1502) or a glucose challenge test (n = 16). There were 101 women diagnosed with GDM, giving an overall incidence rate of 6.6% (prenatal clinic, 7.1%; shared-care, 6.6%; private patients, 6.3%). The most recent midwives data indicate an incidence of 5.7% at the public hospitals and 3.1% at the private hospital. It is thus apparent that the official statistics still underestimate the incidence of GDM. A similar degree of error may also be found for other entries, and hence data should be extrapolated with caution. A redesign of the collection form may help remove some of the errors and omissions. For the question regarding GDM, we feel accuracy could be enhanced if there were separate “Yes” and “No” boxes, rather than a single check box. This might encourage further consideration of the problem. Accuracy could be further enhanced by allowing space for the glucose tolerance test results at 0 and 2 hours — these would also be useful data in their own right.

Robert G Moses · Alison J Webb · Christine D Comber

Lee K Taylor Manager, Surveillance Methods, Centre for Epidemiology and Research, NSW Department of Health, Locked Bag 961, North Sydney, NSW 2059. ltaylATdoh.health.nsw.gov.au In reply: Moses et al are correct in noting that gestational diabetes mellitus (GDM) is under-reported to the New South Wales Midwives Data Collection (MDC). The most recent validation study of the MDC was carried out in 1998. We reviewed a random sample of 1680 medical records from NSW public and private hospitals, representing 1.9% of births reported in 1998. The sensitivity and specificity of reporting of GDM to the MDC were 86.7% and 99.6%, respectively.1 In this sample, the incidence rate of GDM was 3.5% according to the MDC, and 4.0% according to the medical record review. These population rates are lower than the rates reported by Moses et al among women attending hospitals in Wollongong. In addition to incomplete recording of diagnosed GDM on the MDC, the low rate of recording of GDM in medical records in our sample suggests that GDM was also under-ascertained at a population level. This is probably due to variations in the implementation of pregnancy screening for GDM between clinicians and across NSW hospitals. In February 2003, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists endorsed the Australian Diabetes in Pregnancy Society GDM Management Guidelines.2 The guidelines recommend universal screening for GDM, noting that selective screening may be appropriate because of limited resources or known low GDM incidence. The suggestions for trying to improve reporting of GDM by redesigning the MDC form are welcome, and we will certainly consider them at the next review. We are also considering using the hospital Inpatient Statistics Collection (ISC), in which discharge diagnoses are classified according to the International Classification of Diseases, as an alternative source of information on maternal morbidity. We are currently reviewing a random sample of 500 medical records of mothers who gave birth in hospitals throughout NSW. The information obtained will be compared with matched ISC records provided to the NSW Department of Health to determine whether the ISC is a more reliable source of information on maternal morbidity than the MDC. In the longer term, I anticipate that the integration of the MDC with computerised medical records in hospitals will also contribute to improved reporting. Under-reporting of maternal morbidity, including GDM, is an issue for all state and territory perinatal data collections in Australia. The information is used for planning and evaluation of healthcare services, so it is important that we get it right. I would like to thank Moses et al for raising this issue.

Lee K Taylor

David Simmons,* Amanda Fieldhouse,† Leslie E Bolitho,‡ Grant J Phelps,§ Rob Ziffer,¶ Gary J Disher** * Professorial Fellow, Department of Rural Health, University of Melbourne, Shepparton; and Professor of Medicine, University of Auckland Waikato Clinical School, Waikato Hospital, Hamilton, New Zealand; † Health Care Consultant, South Yarra, VIC; ‡ Physician, Wangaratta, VIC; § Physician, St John of God Hospital, Ballarat, VIC; ¶ Physician, Sale, VIC; ** Deputy Director – Health Policy, Royal Australasian College of Physicians, Sydney, NSW. simmonsdATwaikatodhb.govt.nz To the Editor: Rural Australia has a substantial shortage of specialist physicians. In 1999, Victoria had 52 specialist physicians for 1.3 million people (a physician to population ratio of 1:25 000).1 The Australian Medical Workforce Advisory Committee recommendation is 1:10 000.2 Although much has been written about the shortage of rural general practitioners, there is little about rural specialist physicians. However, evidence from Western Australia showed that advanced trainee physicians interested in rural practice were diverted to city-based practice during their training.3 Here, we outline a state-wide approach to encourage advanced trainee physicians to complete their training in rural Victoria. The University of Melbourne Department of Rural Health in Shepparton provided support for rural Victorian physicians to develop a state-wide network, the Victorian Rural Physicians Network, under the Victorian State Committee of the Royal Australasian College of Physicians (RACP). A pilot survey in the 14 major rural Victorian centres demonstrated capacity for at least nine Advanced Physician Trainee positions across rural Victoria. The RACP accredited five positions initially, with others to be reviewed for accreditation if required. These positions were funded largely by the joint Federal–State Government Advanced Specialist Training Program in Rural Australia. Four trainees completed 12 months of rural training in 1999–2000, and three are now working as rural physicians. These trainees were recruited through advertisements in the RACP newsletter and personal contacts. The trainees provided substantial benefits, both in service delivery, as their presence reduced the load on other doctors in the same hospital, and in medical education, as they provided more education and supervision for junior doctors and doctors from overseas. In 2001, a similar approach to recruitment identified eight potential applicants, but none came to interview. In 2002, three new strategies were therefore introduced: Flexible, joint rural–metropolitan positions were created; A rural physicians’ conference was organised;4,5 and A management consultant was employed to contact personally all 99 Victorian basic physician trainees expected to enter advanced training. The response to the new approach is shown in the Box. A third of contactable trainees indicated an interest in rural practice at the end of their basic training. Ten applications were received for the rural training positions, and seven trainees were appointed (three withdrew). We believe that our new strategies have merit, and that the personal touch has created goodwill which may improve the response for 2004. Recruiting for the 2003 Advanced Physician Training Programme for Rural Victoria

David Simmons · Amanda Fieldhouse · Leslie E Bolitho · Grant J Phelps · Rob Ziffer · Gary J Disher

Nicholas A Tonti-Filippini Consultant Ethicist, 15 Alburnum Crescent, Lower Templestowe, VIC 3107. ntfATcyberspace.net.au. To the Editor: Jansen’s study1 of the effect of maternal age on IVF outcome yields information that has not been available. However, the presentation of the data raises two questions. Firstly, are the births reported all attributable to IVF intervention? A couple is considered infertile if they are unable to achieve conception after a year of unprotected intercourse, or the mother is unable to carry a pregnancy to a live birth.2 In reports of infertility, there is a natural conception rate of about 25%–30% per annum,3-6 and Jansen’s study, in effect, covers a 3-year period (or 4 years if you include the period for assessing the outcome of the pregnancies). We need to know whether natural conception has contributed; whether the couples continued to have unprotected intercourse during the course of the study; and what means was used to identify a pregnancy as an IVF pregnancy (as distinct from a natural conception, if that distinction was made). Jansen notes that there was a group of women who dropped out after treatments were initiated and before egg retrieval, and a further group for whom eggs could not be retrieved. It is unclear whether the former included those who had a natural conception. In terms of evaluating the success of IVF, more information on these groups would be valuable. The second question relates to comparative embryo survival rates. Jansen gives the number of live births per egg retrieval procedure, and fresh and frozen embryo transfer is combined in the live-birth result. Separating live embryo transfer from frozen embryo transfer, which is done in the Victorian Infertility Treatment Authority annual reports 1998–2001, would indicate that the transfer of a fresh embryo has about a 9.5% chance of resulting in a live birth, and the transfer of a frozen embryo has about a 3.1% chance of resulting in a live birth. In the current discussion of embryos being available for research, this information about embryo survival rates would be informative.

Nicholas A Tonti-Filippini

Robert P S Jansen Medical Director, Sydney IVF, 4 O’Connell Street, Sydney, NSW 2000. robert.jansenATsivf.com.au In reply: The pregnancies and live births I reported are all attributable to IVF intervention. The physiological and pharmacological reasons for this certainty follow. Firstly, neither an egg-retrieval treatment nor an embryo-transfer treatment (both of which require hormone administration from the start of menstruation) can be embarked on if a woman is pregnant. This is established not just by the fact of menstrual bleeding, but by showing low levels of oestradiol and progesterone. Thus, no treatment cancellations or retrieval failures were for reasons of pregnancy. In an egg-retrieval treatment cycle, preovulatory eggs are removed from mature follicles with high efficiency, and so are not available to be ovulated, which virtually precludes natural conception in the retrieval cycle. As described in my article, transfer of cryostored embryos occurs during a month in which the ovaries are suppressed by the cyclical regimen of ethinyl oestradiol and a progestin (used to develop the endometrium predictably). The effect is that of the sequential oral contraceptive regimens of the 1960s,1 and ovulation is reliably inhibited. Tonti-Filippini’s estimate of a 25%–30% annual natural pregnancy likelihood with just 12 months’ infertility would be more or less correct for couples in their 20s, but does not pertain to our population (median age, 36 years; median duration of infertility, 3.5 years). The arithmetic that predicts an expected, approximately 5% annual natural conception for such a population is given in Jansen.2 The time during which natural pregnancy could have occurred began with the month after the egg-retrieval cycle and ended, as reported, with the month before either (a) an embryo transfer resulted in a live birth, or (b) the last stored embryo from that retrieval was transferred. There were no natural conceptions that we know of, but, even if there were, such pregnancies would not and could not have been attributed to IVF treatment. Thus, the published figures are reliable. I reported the implantation rate per embryo for women under the age of 35 as 24.7%. Subtracting the reported 10.5% miscarriage risk yields a live-birth rate of 24.7% minus (24.7% × 0.105), or about 22% per embryo transferred, which is indistinguishable from the expected 20% natural monthly fertility rates among normal couples of this age group.3 Similar calculations yield 11% live births per embryo for those 35–39 years, and 4% live births for those over 40 years. With present practices at Sydney IVF (Day 5 blastocyst transfers, generally single embryos), the chance of a baby per embryo transferred is 41% (< 35 years), 24% (35–39 years) and 12% (> 40 years). The embryo implantation and live birth data Tonti-Filippini reveals for live births per embryo in Victoria are therefore very low compared with the IVF results I report.

Robert P S Jansen

Corrine R Balit,* Geoffrey K Isbister,† Andrew H Dawson,‡ Frank F Daly,§ Ian M Whyte‡ * Research Pharmacist, NSW Poisons Information Centre, The Children's Hospital, Locked Bag 4001, Westmead, NSW 2145; † Lecturer and Clinical Toxicologist, ‡ Associate Professor, Newcastle Mater Misericordiae Hospital and the University of Newcastle, Newcastle, NSW; § Clinical Toxicologist, Royal Perth Hospital and University of Western Australia, Perth, WA. corrinebalitATaol.com To the Editor: Paracetamol availability is an important public health issue. Kisely et al have further investigated the impact of two paracetamol recall periods on analgesic poisoning using a dataset derived from hospital admissions.1 We are concerned about the robustness of data that uses ICD codes, because of significant coding problems that occur with poisoning admissions. The aim of their study was as a follow-up to our own,2 to look at the impact of removing paracetamol tablets from the shelf during a recall period. Availability is reported to be the most common reason for patients choosing to take paracetamol in overdose3 and, as such, has the potential to affect acute deliberate self-poisoning. However, Kisely et al recognised that it was difficult for them to distinguish between intentional and unintentional ingestions because of the limitations of their dataset1 and hence they considered both of these together. This is inappropriate if the aim is to assess the effect of availability on paracetamol deliberate self-poisoning. For example, there is no evidence that presentations with therapeutic errors in dosing are related to availability and these should be excluded. This is not possible by using ICD codes and was therefore not done by Kisely et al.1 In addition, it is only relevant to include accidental ingestions of tablet formulations of paracetamol, because only these were affected by the recall. There are significant numbers of presentations of children, who accidentally ingest liquid formulations of paracetamol (hence not related to the recall period), that are coded as paracetamol admissions. This introduces a further significant potential bias in the Kisely study. A more concerning problem is the reliability of ICD coding in separating out different analgesics. Poisoning with prescription products such as paracetamol-codeine combination analgesics, which were not affected by the recall period, are also likely to be included in the study being coded as T39.1 (paracetamol overdoses).1 There are significant limitations in using ICD codes, resulting in the dataset analysed not being a true reflection of the impact of the recall of paracetamol tablets. Our study took into account only tablet formulations of the paracetamol alone compounds.2 Paracetamol ingestions following therapeutic error were excluded and accidental ingestions of only tablet formulations were included. While the numbers in the study were small for the hospital presentations, the data set for the NSW Poisons Information Centre was much larger and showed significant increases in intentional and accidental ingestions of ibuprofen, the next most available analgesic.2 In an environment where paracetamol restriction is a hotly debated topic, particularly in light of recent coroners’ cases, it is vital to consider the impact of paracetamol restriction on all types of deliberate self-poisoning by using an appropriate dataset that reflects the measures taken to reduce availability. The challenge for state and federal health departments is to fund appropriate postmarketing toxicovigilance for accidental and intentional self-poisoning in order to clarify these important public health issues.

Corrine R Balit · Geoffrey K Isbister · Andrew H Dawson · Frank F Daly · Ian M Whyte