Women's health

A recent High Court decision has held that parents are entitled, in addition to the usual costs arising from a failed sterilisation, to the reasonable costs of raising a healthy child. In the recent case of Melchior v Cattanach and State of Queensland, a majority in the Queensland Court of Appeal1 and in the High Court2 upheld the finding by the trial judge (Holmes J) that a doctor must pay for all the reasonable costs of raising Jordan Melchior, a healthy boy born as a result of a failed sterilisation. The defendant doctor’s negligence was said to consist of an unreasonable reliance on the history he was given by the plaintiff that her right fallopian tube had been removed, together with her right ovary, during an appendicectomy some 15 years earlier. In fact, the right tube was present and patent. (The doctor’s postoperative notes, after performing a left tubal ligation, stated “Good view small bowel associated with right adnexal area — extensive adhesions. No right tube or ovary visible. Consistent with patient’s history of right salpingo-oophorectomy.” We now know that the right fallopian tube was obscured from view by the bowel adhesions.) Holmes J doubted “that the history [the doctor] obtained could be described in any more than a superficial sense, although he clearly perceived it as so. A little more probing may well have revealed its dubious quality.” Her Honour concluded that, in the circumstances, it was incumbent on the doctor to advise the patient that a procedure (namely, a hysterosalpingogram) was available for detecting whether a functioning fallopian tube was present. I believe that the finding of negligence was highly dubious. It was certainly received less than enthusiastically by the Court of Appeal. In the judgment handed down by the Court of Appeal,1 the sole reference to the issue of negligence was by Thomas J, who stated, “With some hesitation I have taken the view that the view taken by the learned trial judge was open, although it is not a view that her Honour was bound to take or that I think I would have taken.” The significance of the case therefore turns on the controversial award of damages for the cost of raising Jordan up to the age of 18 years. Throughout the case presented at the trial and on appeal (and, indeed, in similar cases in the United Kingdom and the United States) the damages (ie, the cost of raising a child conceived as a result of a failed sterilisation) were labelled as flowing from a “wrongful birth” (ie, a birth that would not have happened except for the defendant’s alleged negligence). That description obscures the reality, namely that Jordan is, in the eyes of the law, an unwanted child whose parents chose to keep him — and sue — rather than mitigate their “loss” by placing the unwanted child for adoption. Has the law any place in the area of human reproduction? In posing that question in the High Court appeal,2 Chief Justice Gleeson, albeit in the minority, answered this question as follows: In deciding whether, in contemplation of the law, the creation of [the parent–child relationship] is actionable damage, it is material to note that it is unlikely that the parties to the relationship, or the community, would regard it as being primarily financial in nature. It is a human relationship, regarded by domestic law and by international standards as fundamental to society. To seek to assign an economic value to the relationship, either positive or negative, in the ordinary case, is neither reasonable nor possible. Without going into the extensive and complex reasoning of each of the judges involved in the case, I will attempt to summarise the views of the majority in the High Court (McHugh, Gummow, Kirby and Callinan JJ), and will briefly discuss the decisions of the dissenting judges (Gleeson CJ, Hayne and Heydon JJ).2 Of the majority, Kirby J (whose views were largely shared by the other judges of the majority) reviewed the relevant law in depth, both in Australia and in the United States, the United Kingdom, Canada, New Zealand and South Africa, as well as the approaches of the civil law in some European countries. His Honour noted that in the United States only a small number of states allow full recovery for the ordinary costs of raising a healthy child born after a failed sterilisation or a failure to adequately warn of potential failure. He further noted that in the United Kingdom the law on the subject had recently veered sharply against awarding damages of the kind at issue in Melchior v Cattanach. In a House of Lords decision, McFarlane v Tayside Health Board,3 their Lordships were unanimous in concluding that the parents of a healthy child, born in consequence of alleged medical malpractice, were not entitled to recover from the doctor the cost of reasonable maintenance of the child during his or her minority. (The word healthy is highlighted here, for reasons that will be discussed below.) Kirby J observed that the common law does not exist in a vacuum and that it had to respond to the ever-increasing claims by disappointed parents who had undergone sterilisation operations — in preference to using contraceptive devices — only to discover that the operations had failed and that they were burdened by an unwanted child and by short-term and long-term losses: What commenced as a relatively small number of cases is now a substantial and growing body of decisional law, not only in common law countries but also in countries with a civil law system.2 In what Kirby J described as an attempt to “stem the tide of such claims”, Jupp J, in the UK case Udale v Bloomsbury Area Health Authority,4 awarded the mother, over and above an amount for pain and suffering and loss of earnings during pregnancy, a small amount for the disturbance of family finances caused by the unexpected conception. However, Jupp J firmly rejected the mother’s claim for the cost of raising the child up to the age of 16, such a claim being regarded as “contrary to public policy, being disruptive of family life and inconsistent with the sanctity of human life”.2 Kirby J continued: As more such cases came before the courts differing views soon emerged. The approach of Jupp J was not followed in a number of the English cases that ensued, including Emeh v Kensington and Chelsea and Westminster Area Health Authority,5 Thake v Maurice6 and Benarr v Kettering Health Authority.7 In those cases, the judges rejected the argument that public policy prevented recovery of damages for the cost of child-rearing [and asserted that] the normal legal principles of recovery of damages would apply. A person injured through the negligence of another could recover damages on the compensatory principle for all losses that were reasonably foreseeable to the tortfeasor [(wrongdoer)] at the time of the wrong. Such losses included . . . the basic costs of child-rearing.”2 It is important to note here that the three cases cited by Kirby J were all first-instance cases whose arguments were soundly rejected by a unanimous House of Lords in McFarlane v Tayside Health Board,3 the first occasion the issue was taken on appeal to the House of Lords. The majority in the High Court having firmly rejected the “English” view (ie, that damages for the cost of child-rearing should not be claimable), their Honours thus gave their imprimatur to earlier Australian cases dealing with an unwanted child, the most significant decision being CES v Superclinics (Australia) Pty Ltd.8 That case was an instance of repeated negligent misdiagnosis of the plaintiff’s pregnancy, thus depriving the mother of the chance to procure a lawful abortion which, she claimed, she would have undergone. On appeal to the New South Wales Court of Appeal (of which Kirby J was then President), the three judges were divided in their opinion. Although Kirby P and Priestley JA both upheld the appeal, they did not agree on the extent of damages the unmarried parents of the unplanned child could recover. Kirby P would have allowed full recovery for the upbringing of the unwanted child. Priestley JA believed that the parents should be entitled to damages relating to the pregnancy and the period shortly afterwards, but not to damages that were too remote or unforeseeable. He argued that . . . after a very short interval, the parents could have surrendered the child for adoption. The mother’s decision to keep the child was her own choice. After that decision was made, the defendant was not legally responsible for the parents’ financial costs of rearing the child. (Restated by Kirby J in the High Court case.2) In his dissenting view in the CES appeal case,8 Meagher JA stated that the parents’ claim was “utterly offensive” and that “there should be rejoicing that the hospital’s mistake bestowed the gift of life upon the child”. He concluded that no damages for rearing the child could be recovered. In Cattanach v Melchior, Kirby J (now a member of the High Court) noted somewhat dismissively, in relation to Meagher JA’s decision in the CES appeal, that “lying deep in many of the judicial opinions are perceptions of moral or ethical factors, illustrated by recourse to Biblical citations.”2 Given such divergent views, Kirby J stated in the High Court that, when sitting in the Court of Appeal, he had reluctantly agreed with Priestley JA, whose views expressed “the highest denominator of the majority”, in order to “provide guidance . . . to trial courts generally”.2 He restated his own view in the High Court: The application of the general rule, requiring the tortfeasor to pay the victims of the wrong for the reasonably foreseeable consequences of any proved negligence, obliges the inclusion in the recoverable damages of a sum for the costs of child-rearing. Clearly such costs are within the ambit of the compensable principle required by “corrective justice”.2 I suggest that the major difference between the majority and minority views in Cattanach v Melchior2 turns, in the main, on whether the law should distinguish between claims of negligence brought by parents who bear a child with a disability and parents who bear a healthy child after a failed sterilisation. Kirby J adopted the view that this differentiation . . . is arbitrary, and therefore unacceptable as a statement of the common law. In Australia, even the description of such parents as “afflicted with a handicapped child” would be offensive to most such parents and contrary to their attitudes about themselves, their child and others.2 The three minority High Court judges, on the other hand, upheld the defendants’ argument that the birth of a normal, healthy child should not be regarded as a legal harm or wrong for which damages may be awarded: [The contrary arguments] are unsound because they take insufficient account of the law’s assumptions about some key values in family life as reflected in the unenacted and enacted law. They also take insufficient account of the type of litigation that is likely to take place if recovery of rearing costs is permitted.2 Against that background, it is interesting to briefly review the speeches of the House of Lords in McFarlane v Tayside Health Board.3 Three of their Lordships (Lords Slynn, Steyn and Hope) characterised the costs of bringing up the child as “pure economic loss”. In denying the claim, these Law Lords identified the relevant question as being “whether the doctor had owed the patient a duty to take reasonable care in giving advice which was a duty that protected the patient’s economic interest”. Lord Slynn concluded that there was no duty of any kind, because the doctor had not assumed a responsibility for the expense of rearing the child. Lord Steyn invoked notions of “corrective” and “distributive” justice, concluding that “commuters on the Underground” would not accept that to impose such a liability would be a “just distribution of the burden and losses among members of the society”. Lord Hope expressly invoked the tripartite test of what is “fair, just and reasonable” — commonly used in the United Kingdom to ascertain the existence of a duty of care — to conclude that “the cost of bringing up the child should not be recoverable while, at the same time, denying that the cost of maintenance had been shown to exceed the value of parenthood”. (Quoted from Hayne J in the High Court case.2) Lord Millett adopted the same view voiced by Meagher JA in the CES case,8 namely that “the law must take the birth of a normal, healthy baby to be a blessing, not a detriment”, adding that, although a mixed blessing, “society must regard the balance as beneficial” and that it would be “subversive of the mores of society for parents to enjoy the advantages of parenthood while transferring to others the responsibility which it entails”.3 It is beyond the scope of this article to examine in detail the views of the High Court judges on the role of “choice” — ie, the exercise of the parents’ choice whether to keep Jordan or place him for adoption, thus exploring the “mitigation” principle enshrined in the law of torts. Neither is it appropriate to discuss at length the role public policy plays in the development of the common law, or, indeed, whether human life can be assigned a monetary value. Suffice it to say that a bare majority agreed that the primary judge was correct in concluding that Dr Cattanach’s “negligence” was the causative — and reasonably foreseeable — factor in the parents incurring the cost of raising Jordan up to the age of 18 years, being an economic loss of a kind for which the defendants were liable. The possibility that Jordan may eventually discover that he was born unwanted produced some caustic observations from some members of the minority. Heydon J noted: Since there is a question whether a rule of law exists which permits parents to recover from negligent defendants the cost of rearing children, it is relevant to consider the consequences of the rule. The rule under consideration would encourage parents both to exaggerate and to denigrate their children’s aptitudes. The rule would encourage parents to search for characteristics of the children which might call for future expenditures with a view to recover monetary compensation to meet those possible expenditures.2 In perhaps the most biting indictment of this “rule”, Heydon J quoted Meagher JA’s warning in the CES case:8 Having given birth to a healthy child in August 1987, the parents claimed at a court hearing in December 1993 that the child, then over six years old, was unwelcome, a misfortune, perhaps a disaster, certainly a head of damages. For all I know the child was in court to witness her mother’s rejection of her. Perhaps, on the other hand, the plaintiff had the taste to keep her child out of court. Even if that be so, it does not mean that the unfortunate infant will never know that her mother has publicly declared her to be unwanted. When she is at school some âme charitable — perhaps the mother of one of her “friends” — can be trusted to direct her attention to the point. That a court of law should sanction such an action seems to me improper to the point of obscenity. In contrast, none of the majority in the High Court dealt with the issue of the potential effect on the child of discovering that he was unwanted and the subject of legal proceedings. I believe the case of Cattanach v Melchior was one in which an unfortunate factual finding, at first instance, gathered its own momentum, allowing judicial adventurism to triumph, the majority accepting a result that other judges regarded as an “obscenity”. The civil law has always shown more caution in imposing tortious liability for negligent acts affecting purely financial interests than it applied to negligent acts causing damage to person or property. At common law, the death of a human being is still a damnum sine injuria (ie, a loss for which the law provides no remedy).9 It required Acts of Parliament in all common law countries to allow specified dependants to sue for damages if death was the result of a negligent act. Why should “legal remedies consequent upon the birth of a healthy child, which all of us regard as a good thing”3 be left to the personal views of common law judges? In the words of Gleeson CJ, quoting from Brennan J in another Australian case,10 “The accepted approach in this country is that the law should develop novel categories incrementally and by analogy with established categories.”2 The majority in the High Court case clearly did not heed that “accepted approach”.

Paul Gerber LLB DJur

Polycystic ovary syndrome (PCOS) is a common condition characterised by menstrual abnormalities and clinical or biochemical features of hyperandrogenism. Features of PCOS may manifest at any age, ranging from childhood (premature puberty), teenage years (hirsutism, menstrual abnormalities), early adulthood and middle life (infertility, glucose intolerance) to later life (diabetes mellitus and cardiovascular disease). While pelvic ultrasound examination is useful, many women without PCOS have polycystic ovaries; ultrasound evidence is not necessary for the diagnosis. Testing for glucose intolerance and hyperlipidaemia is wise, especially in obese women, as diabetes mellitus is common in PCOS. Lifestyle changes as recommended in diabetes are fundamental for treatment; addition of insulin-sensitising agents (eg, metformin) may be valuable in circumstances such as anovulatory infertility. Infertility can be treated successfully in most women by diet and exercise, clomiphene citrate with or without metformin, ovarian drilling, or ovulation induction with gonadotrophins; in-vitro fertilisation should be avoided unless there are other indications.

Robert J Norman MD, FRANZCOG, FRCPA · Ruijin Wu MD, PhD · Marcin T Stankiewicz MRANZCOG

For women with early breast cancer, multidisciplinary care has the potential to reduce mortality, improve quality of life and reduce healthcare costs. In Australia, the diversity of healthcare delivery settings and types of care means that a single model of multidisciplinary care may not be appropriate. The “Principles of multidisciplinary care” were developed to provide a flexible framework for the provision of multidisciplinary care in Australia. The Principles emphasise five key elements: the team, communication, access to the full range of therapies, standards of care and involvement of the woman. This flexible, principle-based approach to multidisciplinary care is unique. The Principles have the potential to be applied to other cancers and other chronic diseases.

Helen Zorbas MB BS · Kathy Rainbird PhD · Karen Luxford PhD · Bruce Barraclough FRACS · Sally Redman PhD

Objective: To review the results of opinion polls on community attitudes to in-vitro fertilisation (IVF) and other aspects of assisted reproductive technology over a 20-year period.Design, setting and participants: Fourteen Australia-wide interview surveys that included questions relating to IVF were carried out between July 1981 and November 2001 as part of regular Morgan polls of community attitudes on various topics. Each survey involved about 1000 respondents drawn from randomly selected “cluster points” in urban and rural locations.Main outcome measures: The proportion of people who approved or disapproved of various aspects of IVF treatment.Results: Support for IVF to help infertile married couples increased from 77% in 1981 to 86% in 2001. Approval for IVF procedures being supported by Medicare funding rose from 70% in 1981 to 79% in 2000.Conclusions: Community approval of the use of IVF to treat infertility has risen significantly in Australia over the past 20 years.

Gabor T Kovacs MD, FRACOG, FRCOG · Gary Morgan BComm · E Carl Wood AC, CBE, FRCS, FRACOG · Donna Howlett BSc, MBA · Catherine Forbes BSc, MSc, PhD

John F Kerin Professor, Reproductive Medicine Unit, University of Adelaide, and Adelaide Fertility and Gyn-Endoscopy Centre, “Timara”, 154 Barton Terrace West, North Adelaide, SA 5006. kerinjfATsenet.com.au To the Editor: In a recent article by Foran,1 information provided on the new Essure (Conceptus, Inc) permanent birth control or sterilisation method was inaccurate in several respects. Firstly, Foran stated, incorrectly, that the Essure method is performed laparoscopically (it is actually a hysteroscopic method). This is a significant error, as one of the unique advantages of this method is the avoidance of incisional surgery, particularly laparoscopy and a general anaesthetic. This hysteroscopic procedure is well tolerated and can be performed with minimal or no sedation, followed by a rapid postprocedure recovery and early return to normal activity.2,3 Secondly, the failure rate in terms of postprocedure pregnancy is much less than the 0.6% quoted by Foran. To date, no pregnancies have been recorded in Phase II2 or Phase III3 multicentre, prospective, single-arm clinical trials conducted according to US Food and Drug Administration guidelines between 1998 and 2003. To date, no pregnancies have occurred in women relying on this intratubal microinsert during a combined 15 635 women-months of follow-up. The effectiveness rate for pregnancy prevention after 2 years of follow-up is 100% (95% CI, 99.5%–100%). Thirdly, it is not a titanium insert. The metal used in the outer dynamic coil is a nickel–titanium alloy commonly known by the trade name Nitinol. Fourthly, the adverse effects claimed (infection, bleeding) are misleading and incorrect. No infections within the uterus, tubes or pelvis have been recorded, and abnormal bleeding is not a feature of this form of sterilisation.2,3 Essure is the first hysteroscopic method of female sterilisation to gain regulatory approval for clinical use (in November 2002). This method of sterilisation offers women the choice of a less invasive, safe and reliable choice of sterilisation in the future.

John F Kerin

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

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

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

Objective: To determine whether high maternal parity has any effect on pregnancy outcome independent of other maternal characteristics.Design and setting: Retrospective observational study using the database of a referral obstetric unit in a 280-bed regional hospital in far north Queensland.Participants: All 15 908 women who had singleton births between 1992 and 2001, comprising 653 women with grand multiparity (≥ 5 previous births at gestation ≥ 20 weeks) and 15 255 women with lower parity.Main outcome measures: Spontaneous vaginal birth, postpartum haemorrhage (estimated blood loss > 500 mL), placental retention requiring manual removal, blood transfusion associated with the birth, and perinatal death.Results: Women with grand multiparity were significantly older than those with lower parity, more likely to be Indigenous, not to have had antenatal care, to have smoked during pregnancy and to have had one or more previous caesarean sections. On univariate analysis, women with grand multiparity were more likely to have a postpartum haemorrhage (9.2% v 5.3%) and blood transfusion (2.8% v 1.5%). However, multivariate logistic regression analysis of women who began labour (ie, did not have an elective caesarean section) showed that grand multiparity was not significantly associated with postpartum haemorrhage or blood transfusion when other maternal characteristics were included in the model (regression coefficients [95% CI], 1.36 [0.99–1.87] and 1.09 [0.59–2.02], respectively). However, they remained more likely to have a spontaneous vaginal birth (regression coefficient [95% CI], 2.10 [1.56–2.74]).Conclusions: Women with grand multiparity do not have an increased likelihood of poor pregnancy outcomes. Birth-suite protocols which dictate extra interventions as routine during labour in these women should be revised.

Michael D Humphrey PhD, FRANZCOG, FRCOG

Objectives: To compare the characteristics of complementary and alternative medicine (CAM) users and non-users among Australian women.Design: Cross-sectional postal questionnaire conducted during 1996, forming the baseline survey of the Australian Longitudinal Study on Women’s Health.Participants: Women aged 18–23 years (n = 14 779), 45–50 years (n = 14 099) and 70–75 years (n = 12 939), randomly selected from the Health Insurance Commission database, with over-sampling of women from rural and remote areas of Australia.Main outcome measures: Consultation with an alternative health practitioner in the 12 months before the survey.Results: Women in the mid-age cohort were more likely to have consulted an alternative health practitioner in the previous year (28%) than women in the younger cohort (19%) or older cohort (15%). In all age groups, CAM users were more likely than CAM non-users to reside in non-urban areas, to report poorer health, have more symptoms and illness, and be higher users of conventional health services.Conclusions: Women in non-urban Australia are more likely to use CAM but do so in in parallel with conventional health services.

Jon Adams PhD · David W Sibbritt PhD · Gary Easthope PhD · Anne F Young PhD

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

Some women with pre-eclampsia develop hypertension and cardiovascular disease in later life Pre-eclampsia Awareness Week (August 17–23) is an opportune time to reflect on what we know about this malady. Why does it develop? Can it be predicted or, more importantly, prevented? What will happen to affected women and their babies with further pregnancy? And, finally, does pre-eclampsia have long-term health effects? About one in 10 pregnancies is complicated by hypertension: about 3%–4% have pre-eclampsia, a similar proportion have gestational hypertension and 1%–2% have pre-existing chronic hypertension. The latter is apparent when hypertension is present in the first half of pregnancy, whereas pre-eclampsia and gestational hypertension usually occur later. Despite pre-eclampsia being a placental disease, the mother rather than the fetus may bear the brunt, with, commonly, increased blood pressure, abnormal kidney (proteinuria or renal insufficiency) or liver function (elevated transaminases or severe right upper quadrant or epigastric pain), neurological disturbances including convulsions (eclampsia), and thrombocytopenia or disseminated intravascular coagulation. The fetus may be affected by growth restriction (about one in four cases), and about 20 per 1000 cases die either in utero or as a result of prematurity. Why does pre-eclampsia occur?There appears to be an ill-defined genetic predisposition to pre-eclampsia, with some studies suggesting an autosomal recessive inheritance. However, discordance for pre-eclampsia among monozygotic twins questions some of the genetic postulates. Paternal influence on fetomaternal genetic mismatch is important, and being born of a pre-eclamptic pregnancy increases the likelihood for males of fathering an infant whose gestation will also be complicated by pre-eclampsia. Immune theories abound, largely arising from epidemiological observations that pre-eclampsia is more common in a first pregnancy, and that changing partners for a subsequent pregnancy increases the risk of pre-eclampsia in women with a previous normal pregnancy and decreases the risk in women with previous pre-eclampsia.1 Prolonged sexual cohabitation before pregnancy appears to protect against pre-eclampsia, the implication being that this allows development of greater maternal “tolerance” to paternal antigens present in sperm or seminal fluid.2 Shallow trophoblast invasion of the placental spiral arteries is common in pre-eclampsia, leaving blood vessels that cannot deliver the same placental blood supply as in normal pregnancies. Although this is a common finding, it also occurs in idiopathic fetal growth restriction in which there are no maternal abnormalities. Thus, the factor (or factors) linking placental underperfusion or relative hypoxia to the multisystem effects of pre-eclampsia is yet to be established. Maynard et al3 have recently reported increased placental production of the soluble fms-like tyrosine kinase 1 (sFlt1) receptor, which mops up circulating vascular endothelium growth factor (VEGF) and placental growth factor. sFlt1 given to pregnant rats caused proteinuria, hypertension and glomerular endotheliosis, all features of human pre-eclampsia.3 Whether this factor proves to be significant in humans remains to be seen. Whatever the factor(s) causing pre-eclampsia, it is best understood as a vasoconstrictive process associated with capillary leak and subsequent reduction in perfusion of maternal kidneys, liver, and brain, as well as the placenta. Can pre-eclampsia be predicted?It follows that without a precise understanding of the aetiology of pre-eclampsia there is little we can do to prevent its occurrence. Nonetheless, it now appears that endothelial dysfunction predates the clinical appearance of pre-eclampsia,4 and we know a range of situations in which pre-eclampsia is more likely. These include primipaternity, essential hypertension, renal disease, multiple pregnancies, donor sperm or donor oocyte pregnancy, history of previous pre-eclampsia or maternal or paternal family history of pre-eclampsia, obesity, diabetes and (probably) thrombophilias, such as Factor V Leiden or prothrombin gene mutations. This allows us to screen such women more often during pregnancy for the emergence of hypertension or fetal growth restriction, although this is not a fail-safe method of detecting all such cases. Taking aspirin 60–150 mg/day from about 14 weeks’ gestation until late pregnancy offers a 15% reduction in the likelihood of developing pre-eclampsia, but about 90 women need to be treated to prevent one such case, and it is difficult to select these women.5 Management of pre-eclampsiaThe development of day assessment units has changed our approach to management of hypertension in pregnancy in Australia. Women with hypertension in the second half of pregnancy previously spent weeks in hospital having their blood pressure controlled. This is now almost always done on an outpatient basis; this applies to women with gestational hypertension (about 25% of whom will develop pre-eclampsia at a later stage) and to a selected number of women with mild pre-eclampsia who have initially been observed in hospital. The Magpie trial6 has shown the benefits of magnesium sulfate for convulsion prophylaxis, but most units in Australia have such low rates of eclampsia (convulsions) that use of magnesium sulfate in all women with pre-eclampsia hardly seems justified. Antihypertensive drugs have been shown to reduce the likelihood of episodes of severe maternal hypertension and fetal respiratory distress syndrome, and several antihypertensive drugs, including oxprenolol, methyldopa, clonidine, hydralazine, and nifedipine, are widely used for this purpose. The most important aspect of managing women with pre-eclampsia is timing of the delivery. This means determining when the woman’s condition is deteriorating or when the fetus is at high risk of intrauterine death. Clearly, such management should be undertaken by highly specialised groups, with a team approach of obstetrician, physician, perinatologist and midwife. What happens after pre-eclampsia?The most common question asked by women who have had pre-eclampsia is whether it will occur in subsequent pregnancies. Estimates of recurrence vary enormously — anywhere from 5%–8% in late onset cases to 25% in early onset cases — but there is a gap in our knowledge about recurrence rates in Australian women. To help prevent pre-eclampsia, the Australasian Society for the Study of Hypertension in Pregnancy recommends low-dose aspirin. Women should take aspirin from early in their pregnancy, if, in the previous (pre-eclamptic) pregnancy, delivery was necessary before 32 weeks’ gestation or fetal death occurred.7 Perhaps the more important question is what effect pre-eclampsia has on long-term health. The traditional view was that having pre-eclampsia imposed no greater long-term cardiovascular risk than a normal pregnancy. However, a recent large study from Norway has shown that developing pre-eclampsia before 37 weeks’ gestation imposes an eightfold increased risk of cardiovascular death over a median follow-up of 13 years.8 Given the young age of women with pre-eclampsia, this is quite a significant finding. Further, a study from Scotland has found that both pre-eclampsia and gestational hypertension increase the risk of hypertension in later life, with women who have had pre-eclampsia having an increased risk of death from stroke.9 Based on these findings, it is reasonable to recommend that all women who have had pre-eclampsia should have their cardiovascular risks assessed regularly (ie, annual blood pressure measurement, assessment of fasting lipids and blood sugar every few years) and should be encouraged to maintain a healthy lifestyle to reduce these long-term risks. ConclusionIn Pre-eclampsia Awareness Week, we know that, for most women with pre-eclampsia in Australia, the outcome is a healthy mother and baby. However, pre-eclampsia should now be thought of as a lifelong disorder, with some women destined in later life to develop hypertension, and cardiovascular and cerebrovascular disease. Indeed, it is this recognition of the long-term health consequences for women with pre-eclampsia that is the more recent important achievement in this field.

Mark A Brown FRACP, MD

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

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

Australia is lagging behind other developed countries in efforts to control chlamydial infection Australian politicians are concerned about the falling fertility rate and are debating measures, such as cash incentives and paid maternity leave, to reverse the “baby bust”.1 If enacted, these measures are expected to cost several hundred million dollars per year — perhaps several thousand dollars per extra baby. Yet, Australia is at high risk of — if not already undergoing — a silent epidemic of preventable infertility and foetal loss through ectopic pregnancy caused by Chlamydia trachomatis infection. This condition can be detected by a $24 test and effectively treated with a single dose of antibiotics. Some commonly held assumptions about chlamydial infection in men need to be addressed. Chlamydial notifications have increased fourfold over the past decade (Box). However, as most infections are asymptomatic, the 26 000 cases reported in 2002 probably represent only a fraction of the true incidence and prevalence.2-4 This trend may be partly due to a reporting artefact or greater numbers or sensitivity of tests.5 Yet, if these factors were the complete explanation, the graph of notifications should have plateaued long ago. The passage of time and enhanced surveillance data6,7 indicate that most of the increase is real. The proposed National Sexual Health Strategy was shelved before the last federal election, and state-initiated Chlamydia programs designed to enhance case-finding through selective testing by general practitioners (and, therefore, Medicare) were discouraged. Australia is overdue to follow the lead of other developed nations by getting serious about controlling chlamydial infection.8 Because infected women are usually asymptomatic, and because they incur the bulk of the serious morbidity, Chlamydia programs have traditionally focused on screening women.9 Selective testing criteria for women include combinations of age under 25 years, reported change of sexual partner, non-use of condoms, unintended pregnancy, and an inflammatory Pap smear result. However, this testing is only secondary prevention — some women identified in this way will already have silent damage to their fallopian tubes and their fertility. True primary prevention mandates that women never acquire chlamydial infection. As there is no vaccine, this means avoiding infection either by behavioural means (use of condoms, non-penetrative sexual practices or sexual abstinence) or by having male partners who are not infected. In this light, some commonly held assumptions about chlamydial infection in men need to be addressed. The first is that men are less likely to be infected than women. Recent population-based surveys in Scandinavia, the United Kingdom and the United States have consistently shown similar chlamydial prevalences among heterosexual men and women.3,4,10 Higher notification rates for women (Box) probably reflect more testing of women than men.7,11,12 Longer duration of infection in women could also be part of the explanation, although how long untreated chlamydial infection can persist in either sex remains uncertain.13 Another apocryphal belief is that the bulk of men with chlamydial infection present for treatment, driven by genital symptoms.9 However, studies in the community have revealed that most men with urethral chlamydial infection, like women, are symptom-free3,4,10 — perhaps as many as three-quarters10 — and that asymptomatic men are less likely than asymptomatic women to present for testing.10 Although there are few data on the duration of chlamydial infection in men,13 it may be months or years. A better understanding of the duration of infection would enhance our ability to model potential interventions. Sweden has a long and much-acclaimed history of screening women for chlamydial infection. This has reduced the prevalence of chlamydial infection and the incidences of both pelvic inflammatory disease and ectopic pregnancy. However, these successes have begun to reverse recently, with the suggestion that Sweden’s failure to test men is a significant reason.8 Since the advent of urine tests for chlamydia, screening men has become feasible and potentially cost effective (using US parameters).12 Without this screening, the success possible with interventions aimed exclusively at women may be limited.8 To determine whether screening of men is justified, more population-based research is required on chlamydial infection in Australian men. The prevalence of infection in different subpopulations would help determine where future screening initiatives are most needed and provide a baseline for evaluating control measures. Factors associated with infection should be identified and assessed as criteria for selective screening. Studies on the natural history of infection and the cost-effectiveness of interventions would also be of global interest. While definitive screening guidelines cannot be promulgated without such data, clinicians could be remiss if a urine test for C. trachomatis was not part of the routine assessment of a young man who reports unprotected sex with a new sexual partner (female or male), regardless of symptoms. More generally, we should be asking what other factors are contributing to the re-emergence of chlamydial and other sexually transmissible infections in Australia. We also need to debate whether single-sex health models can sometimes ultimately harm women. Most women live in an environment that is also populated by men. Chlamydia trachomatis notifications in Australia Source: National Centre in HIV Epidemiology and Clinical Research (http://www.med.unsw.edu.au/nchecr/)

Marcus Y Chen MRCP, DTM · Basil Donovan MD, FACSHP

In Victoria, decisions regarding late termination of pregnancy no longer involve just pregnant women and their clinicians. At two major women's hospitals, committees now govern the decision-making process for approval of a late termination of pregnancy. The legal and ethical implications of clinical decision-making by committee need to be widely debated. decision-making processes for termination of pregnancy after 20 weeks' gestation have recently changed in Victoria. Most late terminations of pregnancy are conducted in the public sector at two major centres for obstetrics and gynaecology: the Royal Women's Hospital, and Monash Medical Centre. Before June 2000, in response to a request for a late termination of pregnancy, the clinicians managing the woman's pregnancy would meet and attempt to reach a consensus as to the appropriateness of a termination in her circumstances. Following the reporting of a late termination of pregnancy to the Victorian Coroner,1 Monash Medical Centre and the Royal Women's Hospital each decided to create a termination review committee (TRC) to deal with the decision-making (Box). The role of each committee is to receive referrals from obstetricians regarding requests for late termination of pregnancy from pregnant women, and to decide whether the request should be approved. Clinical decision-making by committeeThere is a growing belief in the medical community that doctors can no longer make important clinical decisions in isolation. This is particularly evident where clinicians have diverse views about the appropriateness of a late termination. The major dilemmas are whether a clinician views the status of the fetus as secondary to the mother's interests, or whether the fetus is a separate entity with rights that can be in conflict with the rights of the pregnant woman. Clinical decision-making by committee can perform several roles, and these depend on whose interests the committee is intended to serve. Expert ethical and legal guidanceA committee may provide expert guidance in areas in which clinicians need assistance, predominantly in clinical ethics and the law, where clinical requests would be assessed in line with current standards. By obtaining appropriate expert guidance, a TRC may protect the community against possible poor ethical or legal decisions by clinicians. LiabilityA committee may accept the bureaucratic responsibility for the care of the patient, including liability. The clinicians become absolved of legal liability for the decision about a late termination. This would serve the interests of doctors, who give up their clinical autonomy to the committee, and are not responsible for the decisions made by the committee in patient care. An attempt has been made by the Royal Women's Hospital TRC to recognise this role (Guidelines for the termination of pregnancy. Royal Women's Hospital, Melbourne, intramural communication). The Royal Women's Hospital guidelines for termination of pregnancy state that "staff will be strongly supported by the Hospital in patient care which is in accordance with these guidelines." However, "staff will be strongly supported" is a weak legal statement to take on legal liability. It is doubtful whether a doctor can absolve himself or herself from legal responsibility. Nevertheless, many clinicians feel supported by ethics committees in making these difficult decisions. They feel it is helpful if a TRC shares with them the responsibility for the decision-making. Avenue of appealA committee may act as an avenue of appeal for the pregnant woman. That is, if the clinician disagreed with the woman's position, she could seek another opinion. In this case, the committee would be set up to serve the interests of the pregnant woman. If the committee came to a different conclusion, it would be required to facilitate a second opinion — either within the hospital, in another hospital, privately or interstate. However, the Victorian TRCs do not act as an avenue of appeal for pregnant women in their current structure. It is the decision of the obstetrician to put forward her case; the pregnant woman has no right to do so herself. In the case of pregnant women denied a termination by a TRC, it is unclear how to offer a second opinion. Obtaining a second opinion outside the major teaching hospitals is not necessarily straightforward. The pregnant woman may have to request the second opinion of her own volition. Although not impossible, it is unlikely that a doctor in Victoria (or perhaps even interstate) would proceed against the decision of a TRC, even if he or she thought the woman had an ethical and legal reason for a late termination. It may be in the pregnant woman's best interests to inform her of this before the case is put before a TRC. Pregnant women can then exercise their autonomy to pursue private or interstate options before these become "closed". Public accountabilityA committee may act to provide public accountability as well as an educative role for clinicians. Public accountability would require that the committee have appropriate representation from the community. The committee would need to publish its cases or make them accessible to clinicians for general examination. Clinical decision-making, whether by a committee or by clinicians, should be publicly accountable. Clearly, this is not the current role of the Victorian TRCs. Ethical considerations of clinical decision-making by committeeInterestsWhose interests does a TRC serve? The major concerns that have been expressed about ethics committees can be levelled at TRCs.2 If a committee is set up to serve the interests of the hospital, then it tends to err on the side of "conservative" decision-making. In late terminations, where the law is unclear, this is to be expected, but this may not be in the interests of pregnant women. A committee could also come under the influence of a particular constituency or lobby group, which might not serve the best interests of either pregnant women or clinicians. This would depend on how members (and their delegates) are co-opted on to the committee, and whether any external process assesses the committee. The pregnant woman's autonomy and a TRCWho is ultimately responsible for a decision? In Victoria, a pregnant woman has no explicit right to demand a review by a TRC, even if she is aware of the inside workings of the process. She cannot attend personally to put her case forward, nor is she able to send a patient advocate, or even a clinician of her choice, to review the process. It must also be remembered that the obstetrician presenting the case may not agree with the woman's decision for a termination, but may bring the case to a TRC anyway. This raises several issues about patient autonomy and informed consent. All the woman's preferences and circumstances are heard second-hand. How strongly her preferences are advanced will depend on the communication from the obstetrician. Should an obstetrician who disagrees with the patient's preference inform the woman before he or she attends a TRC? As a legal question, this may be extending the disclosure principle to its limit, as patients have no right to demand that a procedure should be provided. However, from an ethical viewpoint, a lack of disclosure may restrict a pregnant woman's autonomy to seek other options. Most members of a TRC do not meet the pregnant woman who is making the request for a termination. This "arm's length" approach may undermine the autonomy of the pregnant woman to argue her case. Anonymity of the membersThe Royal Women's Hospital TRC insists on anonymity for its members. The hospital administration is concerned that if names of the members of the TRC were available outside the hospital, members risked being victimised and stalked, as occurred with a former senior consultant in the 1970s (Review of Royal Women's Hospital TOP [termination of pregnancy] Working Party. Notes of meeting number 1. 17 October 2000, intramural communication). The inconsistency in this defence of anonymity is that the doctor performing the termination of pregnancy is not anonymous, nor are the doctors counselling the pregnant woman. It could be argued that the people most at risk of a political act of violence are the clinicians, not the members of the Royal Women's Hospital TRC. The ethical difficulty is who takes the responsibility for the decision-making if committee members are anonymous. An attempt is made to offer support to the clinician by the Chairman of the Royal Women's Hospital TRC "signing off" on the patient's chart. Third-party considerations The Royal Women's Hospital TRC considers the "desires of the father, other children and familial circumstances" in evaluating the appropriateness of a termination. Third-party considerations for termination of pregnancy have no standing in Australian law. The countries which do have "third-party authorisation" for terminations of pregnancy (eg, Morocco, which requires a husband to authorise his wife's abortion) are considered to have the most restrictive laws on abortion.3 How can a TRC consider the desires of the father or other children without asking them for their opinion? Does this contravene our privacy laws and our commitment to our patient's privacy? The intention of this clause is unclear, but I have reservations that our care for pregnant women may be harmed by third-party considerations. ConclusionWhile we are waiting for a legal solution, women will continue to attend clinicians requesting late termination of pregnancy. Further research needs to be performed on the impact that clinical decision-making by committees has on the effective care of pregnant women. In particular, we need to review the psychological effects on women who were denied a termination by a TRC. Clinicians need support in making controversial and difficult ethical decisions. Clinical ethics committees can provide support and advice, particularly in clinical ethics and the law, but should they take over clinical decision-making? This alienates both the pregnant woman and the clinicians, and may lead to inappropriate clinical care. The committee must not erode the doctor–patient relationship, which provides a framework for mutual decision-making. It is the setting where patients make many of their difficult quality-of-life decisions. Each case is unique and there is no right answer when a pregnant woman asks, "Doctor, what would you do?". We live in a pluralistic society with diverse views on abortion. Why should the decision of a committee, which bears no long-term responsibility for the unborn child, prevail over an informed, conscientious, pregnant woman, especially when there is no sound legal basis for the committee's decision-making? Termination review committees in Melbourne, Victoria Why were they formed? The Royal Women's Hospital Executive created a termination review committee in June 2000, following widespread publicity of a controversial late termination of pregnancy. The hospital created a set of guidelines for late termination to be referred to the TRC as "hospital policy". The TRC was formed to ensure that hospital administration approved all late terminations performed within the hospital. The hospital administration believed that this was the best way to protect itself, clinicians and patients from possible poor decision-making by doctors. A TRC was also formed at Monash Medical Centre in July 2000. The initiative came from clinicians who wished to formalise the process that was already in place for approving a late termination of pregnancy. The clinicians believed that a formal process would improve communication with the hospital administration and lawyers, and ensure all options were explored before a late termination was performed. What are the terms of reference of the committees? The committees deal with the decision-making for approval of all terminations of pregnancy at or after "viability" (22–24 weeks' gestation) to be performed within the hospital. Their role is to assess a request for a termination in line with their interpretation of current Victorian law. The committees are also responsible for ensuring adequate consultation, counselling and documentation before the approval of a late termination. Who are the members? Royal Women's Hospital: A member of the executive (eg, Chief Executive Officer, Executive Director [medical or nursing]), a neonatal paediatrician, two medical divisional directors, one nursing divisional director, and the obstetrician managing the pregnancy. Delegates may be used in some cases. The committee may co-opt non-voting members with relevant clinical, legal and ethical skills. Monash Medical Centre: The clinicians involved in the woman's care (obstetrician, ultrasonologist, geneticist, paediatrician, labour ward midwives, resident staff) and a general practitioner practising outside the hospital. Opinion may be sought from a member of the hospital executive and the hospital lawyer. How do the committees make decisions? Initially, the pregnant woman has a consultation with her clinicians. After comprehensive counselling, she may request a termination of pregnancy. Requests for termination may be in the setting of an obstetric complication, a medical or psychiatric illness, or a fetal abnormality. The clinicians meet to decide if they believe that the request should be upheld and if this requires approval from a TRC. The referral to a TRC comes from the obstetrician, not from the pregnant woman. In arriving at a decision, the TRC needs to compare the consequences for the pregnant woman if she has a termination, if she continues the pregnancy and cares for the child, or if she gives up the child for adoption. Other considerations include the extent and severity of a fetal abnormality, and the physical, psychological and social circumstances of the pregnant woman. At the TRC, an attempt is made at consensus, but if necessary, decisions are made by majority vote. The clinician is bound by the decision of the committee. The Monash Medical Centre model differs from the Royal Women's Hospital model in that opinion from the hospital executive and lawyer is consultative rather than prescriptive in nature. The final decision is made by the pregnant woman, her clinicians and an independent GP. Both committees can be convened and decisions made within days of a request being put forward.

Nicole L Woodrow FRACOG

Objectives: To examine the frequency of post-antibiotic vulvovaginitis (PAV); describe how women prevent and treat PAV; and determine whether concern about PAV affects their decisions about taking antibiotics.Design: Cross-sectional survey using a written questionnaire.Setting and participants: Five general practice waiting rooms in north-western Melbourne, in February 2000. 1298 women aged 18–70 years were surveyed.Main outcome measures: Self-reported symptoms and management of vulvovaginitis and PAV.Results: The response rate was 86%. Thirty-five per cent of women reported ever having PAV and 73% reported ever having symptoms suggestive of vulvovaginal candidiasis. Antifungal medications and lactobacillus products or yoghurt were most popular for both prevention (49%, 40%) and treatment (63%, 43%) of PAV. Other home remedies such as tea tree oil, vinegar, and dietary and clothing modification were infrequently used by the women surveyed. Twenty-three per cent of women who had taken antibiotics in the previous month had experienced symptoms of vulvovaginitis. Of women who had ever had vulvovaginitis, 35% were moderately to very concerned about developing PAV when prescribed antibiotics. Because of this concern, around a fifth of these women would not take prescribed antibiotics.Conclusions: Concern about PAV affects women's decision-making regarding antibiotic use. Many women use unproven complementary therapies to prevent or treat PAV. When prescribing antibiotics, doctors should discuss the risks of PAV and its management with patients.

Marie V Pirotta MMed, FRACGP, DRANZCOG, GradDipEpiBiostats · Jane M Gunn PhD, FRACGP, DRANZCOG · Patty Chondros BSc(Hons) GradDipEpiBiostat, MSc(Statistics)

Sex analyses in studies can have clinical implications In the past decade, biomedical and behavioural research has provided evidential credibility for the field popularly known as "women's health".1,2 During this time, heightened interest and increased resources were given to the study of "conditions unique to women",3 and to sex and gender differences in health.4 These efforts have increased our understanding of the aetiology, prevention, management and health outcomes of many conditions that affect women.5 In doing so, this research has progressively widened its focus from reproductive conditions to concepts of health throughout women's lives. It has also influenced the culture of science and the paradigms by which scientific studies are now designed and conducted.1,6 Policies for research supported by the US National Institutes of Health (NIH) now mandate the involvement of sufficient numbers of women in studies to determine whether sex/gender differences exist. The US Institute of Medicine of the National Academy of Sciences has recommended that researchers should disclose the sex of origin of cell and tissue cultures used in research; and biomedical journals are beginning to recommend that investigators report analysis of data by sex.7 Research continues to document many sex/gender health differences (Box 1 and Box 2) and is beginning to define gender-specific preventive measures, risk factors, or treatments. For example, different clinical manifestations of heart disease in women have been noted,8 as have potentially fatal sex-based arrhythmias for women in response to some cardiac drugs.9 Another example of how results from sex analyses in studies can have clinical implications is the demonstration that women are more likely to have a lower threshold for pain and may be more responsive to some analgesics such as kappa-opioids.10 In the United States, the drive for dedicated women's health research came from public policy and grassroots activists.11 In response, the NIH established the Office of Research on Women's Health (ORWH) within the Office of the NIH Director in 1990.12,13 The ORWH advises the NIH Director and staff on women's health research matters; ensures that NIH-supported research adequately addresses women's health issues; ensures that women are appropriately represented in biomedical or behavioural research; and, develops opportunities for and supports the involvement and advancement of women in biomedical careers. Other agencies within the US Department of Health and Human Services address aspects of women's health that fall within their mission, including healthcare services, drug regulation, or health policy.14 It was subsequent to the initial research agenda on women's health in 1992,15 that the ORWH emphasised research that encompassed the totality of factors influencing women's health across the life span. Since 1999, with the eight-volume Agenda for research on women's health for the 21st century,16 increased emphasis is now given to interdisciplinary research, disease prevention, analysis of research data by sex/gender and the inclusion of diverse populations of women in studies. This is to enable the exploration of factors that contribute to differences in health outcomes and in responses to therapeutic interventions. Research priorities are directed to: the relationships between early life activities and health or ill health in later life; the role of personal behaviours and lifestyle choices in the health and ageing processes (focusing on such issues as obesity, exercise, addiction, and smoking cessation); and many other delineated areas. These include multisystem disorders, mental health and addiction, complementary and alternative medicines, violence and quality of life. A January 2003 workshop sponsored by the ORWH in Washington, DC, "Science meets reality: recruitment and retention of women in clinical studies and the critical role of relevance", examined the lessons we have learned from the past decade such as: ways to recruit and retain women in clinical studies; the importance of community participation in the design and planning of a study to facilitate recruitment of participants from that community; how investigators can better communicate with potential volunteers, show respect for vulnerable people and avoid the use of coercive recruitment tactics; and the means to ensure that clinical research is relevant and targets questions important to public health. The workshop also identified emerging ethical and policy issues including: the need to appreciate how sex differences should be taken into account in the design of clinical research; the shift from the ethics of protectionism (that often resulted in exclusion of women, especially pregnant women or women of childbearing age, from research to "protect" them from harm) to the ethics of inclusion (recognising the need to include women of all ages in studies as long as the potential results would not cause harm); concepts of justice in research, such that potentially beneficial research would not just be offered to one group of volunteers or patients, and that all populations subject to a disease or condition have the right to be studied — a concept embodied in the NIH policies requiring the inclusion of women (and minorities) in human subject research; and, the differences between clinical care and clinical research. Finally, one of the most critically important issues is the translation of clinical research into practice, which becomes especially apparent when research outcomes contradict established clinical practice.17 This happened in 2002 when the outcomes of the oestrogen/progestin postmenopausal hormone therapy arm of the NIH-funded Women's Health Initiative randomised controlled trial became available.18,19 The study provided definitive evidence that long-term therapy with combination oestrogen and progestin does not reduce cardiovascular disease in postmenopausal women (as had long been thought), but rather had unexpected results — showing an increased risk for cardiovascular disease as well as an increase in risk for breast cancer. Such studies provide strong justification for continuing research to document risks versus benefits of common, but unproven, approaches to disease prevention and treatment of women. At present, efforts focusing on translating research findings into healthcare include the Specialized Centers of Research on Sex and Gender Factors Affecting Women's Health, an innovative initiative which supports both basic and clinical projects related to research priorities that can advance scientific discoveries from "bench to bedside".20 Research on women's health and sex and gender factors is providing the data with which to better arm the physician for possible variations in approaches, drug dosages, or diagnostic practices for not only women but also men. This new knowledge is creating new challenges to ensure that future physicians possess a full understanding of how to better provide gender-appropriate healthcare.21-23 1: Definitions Sex: refers to being male or female according to reproductive organs and functions assigned by chromosomal complement Gender: refers to socially defined and derived expectations and roles rooted in biology and shaped by environment and experience 2: Known sex/gender health differences Heart disease: presentation, outcomes, and responses to intervention HIV/AIDS: manifestations and progression Pain: response to pain and pain therapies Depression: clinical features and management Diabetes: prevalence and care, especially type 2 diabetes Musculoskeletal diseases: incidence and effect; eg, of osteoarthritis, osteoporosis and sports injuries Autoimmune diseases: mortality

Vivian W Pinn MD

Healthy risk-taking is a normal part of adolescence. Young people who participate in multiple risk-taking increase the chance of damaging their health. There appears to be a growing range and prevalence of health-risk behaviours among young women, notably in their use of alcohol and marijuana. Research suggests that such health-risk behaviours may be related to psychological factors such as stress and depression. General practitioners have a central role in identifying and preventing health-risk behaviours and associated mental health problems in young people. Comprehensive assessment includes a series of screening questions about home, education (or employment), activities, drugs, sexuality and suicide for young people, known as the HEADSS technique.

Michael RC Carr-Gregg BA(Hons), MA, PhD, MAPS · Kate C Enderby BA, GradDipHealthPsych · Sonia R Grover MB BS, FRACOG

Many young women feel that body image and exercise are important for their self-esteem, want to lose weight, are afraid they might gain weight, and feel fat. Interventions that improve self-esteem, encourage communication and help adolescents to be supportive of each other may prevent some of these women from developing eating disorders. If an eating disorder is suspected, it may be useful for physicians to ask about fear of loss of control over the body, eating, weight and shape; and preoccupation with food, eating, nutrition, body weight and shape, as these issues may differentiate those at greater risk.

Suzanne F Abraham MSc, PhD