Women's health

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

The women who can most afford motherhood are the least likely to have babies Young women today think long and hard about when, and even whether, to become mothers. They observe the changes that occur in their sisters' or friends' lives when they have babies; changes that are for the most part dramatic and, of course, irreversible, and it gives them serious pause for thought. It is not something most of them are going to do until they are really, really sure that it is the right thing — and the right time — for them. Most young women want to wait until they have experienced the world, then acquired a financial base and made sure they are with the right man before embarking on the long journey of parenthood. Sometimes, after waiting until their early 30s to get everything in place, they find they can't bring themselves to change. They are not sure they can cope with the dislocation and chaos a baby will bring into their lives. There is a big decision to be made and, for the first time in history, women are in control of that decision. Exercising it gives them a great sense of power — and a freedom previous generations of women could not even have dreamed of. Australian women today are the first generation to effectively have total control of their fertility and this has dramatically changed everything for them. One hundred and fifty years ago, nearly half of all Australian women could expect to have around nine confinements.1 Early in the 20th century, it was not uncommon for a woman to have "a toddler at her skirt, another at her breast and a third in her womb".2 Less than 50 years ago, in 1961, women were having on average 3.6 children each. Today, around 28% of women will not have children at all and those who do have them are having fewer than any previous generation. In 1993, the fertility rate in Australia (the number of babies a woman will bear over her lifetime) was 1.9, down from 2.1 in 1976. The 1970s rate was the same as the previous lowest level — in 1934, during the Great Depression. Rural women still have more babies — an average of 2.27 in 2001, and the rate for Indigenous women was 2.21, whereas in the same year the national average birth rate had fallen further to 1.7. In some areas it is even lower, for instance in metropolitan Melbourne, which has a birth rate of just over 1.5. A birth rate of 2.1 is required for a country to reproduce itself, so Australia now has to rely on immigration just to maintain its population. This phenomenon of a dramatically declining birth rate is sometimes called the "baby bust" — in contrast to the post-World War II "baby boom", from 1946 to 1963, during which Australia's birth rate soared. Demographers, politicians, editorialists and others are constantly fulminating against this decline. What can they do (they bluster with increasing frustration) to make women have more babies? Why are women having fewer and fewer babies? The reasons are complicated, but the answer in some ways is surprisingly simple. As a society, we ask women to give up too much when they have children and we give them far too little in return. The pleasures of children are, in the pragmatic calculus now undertaken by most young Australian women, not compensated for by what they have to forgo. They are expected to give up their jobs or at least cut back on them, often after having been given a hard time while they were pregnant. They can expect to suffer a significant loss in earnings, from which over a lifetime they will never recover, as they will rarely be able to return to do the same level of work as before. Even the government admits that stopping work to have a child means "the family cash income will drop sharply". According to Fact Sheets on Work and Family issued in 2002 by Senator Amanda Vanstone, the federal Minister for Family and Community Services, when a double-income family, both on average weekly earnings, moves to a single income, they suffer a 38% fall in income that government payments do not come close to redressing. Economist Dr Bruce Chapman from the Australian National University and others have calculated that a woman who has completed secondary education will forgo lifetime earnings, after tax, of around $160 000 for a first child, and about $12 000–$15 000 for each additional child.3 Unlike a similarly industrialised country such as the United States, where mothers are far more likely to return to full-time work even when their children are quite small, Australia seldom makes this a feasible option for new mothers who wish to retain an attachment to the full-time workforce. As a consequence, it will be difficult for mothers to hang on to their skills, let alone to upgrade them so they can keep up with their former colleagues. There are now clear trends showing that the more educated a woman is, and the higher her income, the fewer children she will have. Women aged 30 years and over with a university or higher degree have the lowest birth rate. Women in this group have slightly less than half the number of children of other, less qualified women of the same age. Since the rate of women's participation in university education is continuing to increase (from 8.4% in 1986–87 to 20.2% in 2000–01),4 it seems likely that the fertility rate will also continue to decline. Professional women are almost twice as likely to be childless as women in clerical and sales occupations, and when fertility is correlated with the socioeconomic status of where women live, those in the highest status areas have less than half the number of children than those in the poorest areas.5 In other words, the women who can most afford motherhood are the least likely to have babies. They know how much they would be giving up in a society that pays lip service to maternity, but which in fact treats mothers very badly. Is it any wonder there is a "baby bust"? As a society we do almost nothing to make it easier for women to combine a satisfying and productive life with having a family. Instead, we place all sorts of obstacles in her way, and we cruelly force her into choices that are unfair and discriminatory. Men expect to be able to have families and still enjoy their jobs or careers and, increasingly, so do women. Women are no longer prepared to sacrifice themselves on the altar of maternity, or to be doormats for their families. They want a life — and they are entitled to have one. If we refuse to let them have it, something has to give and, as we have already had amply demonstrated to us over the past 10 years, that something will be having children. Finally, women — younger women especially — are starting to put themselves first.

Anne Summers AO PhD

The epidemic is subsiding as we improve the delivery of assisted reproductive technology The multiple birth rate in Victoria rose from 12 to 17 per 1000 pregnancies between 1986 and 1997.1 There were comparable increases in the United Kingdom and United States. During this period, the rate of all multiple births increased, but the more significant increases were in high-order multiple pregnancies. In Victoria, the triplet pregnancy rate increased more than three-fold from 0.19 to 0.61 per 1000 pregnancies between 1986 and 1998.1 There was a similar three-fold rise in the rate of triplet pregnancies in the United Kingdom,2 while in the United States, the rise was six-fold for triplets and 12-fold for quadruplets.3 These rates of multiple pregnancies peaked at the end of the century and are now slowly falling. There are several reasons why there has been an increase in twin pregnancies and the "epidemic" of high-order multiple pregnancies with low birth rates in the developed world. Monozygotic twinningMonozygotic twinning occurs independently of ethnicity, maternal age, parity, nutritional status and environmental factors. It is a random genetic event occurring in 1 in 250 pregnancies. Although the incidence of monozygotic twinning may be doubled after induction of ovulation, and is increased with in-vitro fertilisation for reasons that are yet to be explained, monozygotic twinning has contributed minimally to the global epidemic of multiple pregnancy. 4,5 Dizygotic twinningIn developed countries, there was a global decline in dizygotic twinning rates from 1960 until the mid-1970s. Although the exact cause remains unknown, this decline has been attributed to either environmental pollutants or a reduction in sperm quality.6 Chronologically, the fall in dizygotic twinning can be attributed to reduced fertility after oral contraceptive pill use became widespread. From the 1980s, the steady increase in dizygotic twinning related to agents that induce ovulation may have masked a true, progressive decline in the spontaneous dizygotic twinning rate.6 The rate of dizygotic twinning is increased in women aged 35–39 years, with higher parity and tall stature. Rates fall in severely malnourished women. Dizygotic twinning runs in families. If a mother or a sister has dizygotic twins, a woman has double the risk of having dizygotic twins herself. If she has dizygotic twins herself, her risk of having future dizygotic twins is quadrupled.7 Folic acid supplementation at the time of conception is widely promoted for reducing the risk of neural tube defects. A systematic review of periconceptual supplementation with folic acid or multivitamins, or both, identified a tendency to an increased risk of twinning (pooled relative risk 1.40; 95% CI, 0.93–2.11).8 It is unclear why such an association exists; possibly folic acid improves early fetal survival rather than promoting multiple ovulation. Assisted reproductionThe most significant cause for the increase in the multiple birth rate in developed countries has been the use of assisted reproductive technology. Inducing ovulation with clomiphene citrate carries an 8% risk of a multiple pregnancy, and with gonadotrophins, a 20% risk. These agents (which act by hyperstimulation of ovarian follicles resulting in one or more oocytes being released per cycle) are responsible for most high-order multiple pregnancies. Ultrasound monitoring can detect the potential for multiple ovulation in a woman's cycle, and she can be advised accordingly. However, even with ultrasound monitoring, and in the most careful and experienced hands, multiple ovulations can occur. With in-vitro fertilisation (IVF) and gamete intrafallopian transfer (GIFT), multiple pregnancy rates vary with maternal age and the number of embryos transferred; a 20% multiple pregnancy rate with double embryo transfer and 25% with triple embryo transfer is typical. The increased use of microinjection techniques has seen an increase in monozygotic multiple pregnancies. Improvements in stimulation and laboratory culture techniques have improved embryo quality and, subsequently, the success of IVF and GIFT, particularly in recent years. Risks of multiple pregnancyObstetric complications occur more frequently in multiple pregnancies (Box 1), and perinatal mortality escalates with increasing fetal number. The most recent Victorian figures indicate a perinatal mortality of 9.2 per 1000 pregnancies for singletons, 42.9 per 1000 for twins (first twin 37.8; second twin 47.9), and 145.5 per 1000 for triplets (first triplet 145.5; second triplet 127.3; third triplet 163.6).1 Preterm delivery is the major cause of adverse outcomes (both short-term and long-term), and is directly related to fetal number (Box 2). The consequences of prematurity (including cerebral palsy, hearing and visual disturbance, behavioural disorders and respiratory disease, among many others) can result in significant social, emotional and financial burdens for families. Costs to the community also increase with the number of infants. Monochorionic twins have specific risks because they share a placenta. These risks are twin–twin transfusion syndrome, twin reversed arterial perfusion sequence, monoamnionicity and conjoined twins. All of these conditions have very significant risks of fetal and neonatal mortality and morbidity. The risks associated with being born in a multiple pregnancy do not end with delivery. Apart from the consequences of prematurity, or the morbidity associated with monochorionicity, children born as twins or in higher order multiple pregnancies have increased rates of neonatal death, speech and reading difficulties, and behavioural disorders including attention deficit hyperactivity disorder. Twins have a four-fold, and triplets a 20-fold, increase in cerebral palsy compared with singletons. If a twin develops cerebral palsy, the risk of its co-twin developing cerebral palsy is 12%. Death of a co-twin increases the risk of cerebral palsy for the survivor to around 5% with the risk rising to 40% with monochorionicity.10,11 Preventing multiple pregnancyAll women undergoing ovulation induction should be offered monitoring of follicular development. They should be fully advised of the potential for a multiple pregnancy, and should be made aware of the consequences of pursuing a conception when multiple follicles are present. It is axiomatic that the fewer the number of embryos transferred after IVF, the lower the risk of a multiple pregnancy. It has been recent practice to offer women the transfer of only two embryos to optimise the chance of pregnancy without significantly increasing the risks of a multiple pregnancy. This practice also helps reduce the costs to the patient associated with repeated embryo transfers. However, with the continuing improvement in pregnancy rates with IVF, single embryo transfer should now be considered by all women, particularly those who are younger and those who already have children. Multifetal pregnancy reduction (MFPR) by intracardiac potassium chloride injection to reduce the number of "excess" fetuses is often seen as the answer to reducing the risks and avoiding the complications of high-order multiple pregnancy. Notwithstanding the social, moral and ethical issues associated with this technique, there are significant risks to the remaining fetuses associated with the procedure. For example, MFPR from a triplet to a twin pregnancy is associated with an 8% risk of miscarriage of the remaining twins. However, the procedure offers a marginal reduction in perinatal mortality and reduces the handicap rate from 1.5% to 0.6% per fetus.12 ConclusionsMultiple pregnancy usually has a satisfactory outcome, culminating in the birth and development of healthy children, often long awaited, and much loved by their parents. However, the consequences of some multiple pregnancies for the parents, the children and the community remain significant. Multiple pregnancies reached epidemic proportions in the late 1990s as a consequence of assisted reproductive technology. The rate is now falling and this trend should continue as practitioners respond with careful monitoring of ovulation induction and with reduced numbers of embryos transferred after IVF. 1: Significant risks associated with twin pregnancies1,2,9 Obstetric complication Risk* Anaemia x2 Pre-eclampsia x3 Eclampsia x4 Antepartum haemorrhage x2 Postpartum haemorrhage x2 Fetal growth restriction x3 Preterm delivery x6 Caesarean section x2 * Compared with singleton pregnancies 2: Rates of preterm delivery by fetal number1 Delivery Number of fetuses < 28 weeks < 37 weeks Singleton 0.7% 6.2% Twins 4.4% 52.1% Triplets 21.8% 98.2%

Mark P Umstad MB BS, MD, MRCOG, FRANZCOG · Michael J Gronow MB BS, MD, MRCOG, FRANZCOG

The range of contraceptive options and consumer awareness of new contraceptive methods have both increased significantly over the past 10 years. New methods available in Australia include lower-dose oral contraceptive pills, new oral progestogens, progestogen implants, a progestogen-bearing intrauterine device and polyurethane female condoms. Contraceptive options which may soon be introduced in Australia include novel methods of administering combined (oestrogen–progestogen) contraception, such as dermal patches and vaginal rings.

Therese M Foran FACSHP

In addition to providing safe and effective contraception, both the combined oral contraceptive pill (COCP) and selected long-acting progestogen-only contraceptives have significant health benefits. The COCP may reduce menstrual blood loss, dysmenorrhoea and premenstrual syndrome; unequivocally reduces the later incidence of endometrial and ovarian cancer; appears to help protect future fertility, probably by reducing the risk of acute pelvic inflammatory disease, endometriosis and uterine fibroids. The quality of evidence for individual non-contraceptive health benefits of the COCP is very variable.

Ian S Fraser MD, FRANZCOG, CREI · Gabor T Kovacs MD, FRANZCOG, FRCOG

The main indication for hormone replacement therapy (HRT) is to control menopausal symptoms and improve quality of life. Ideally, withdrawal of HRT should be attempted after 4–5 years of therapy. HRT reduces fracture risk and remains appropriate therapy for osteoporosis, particularly in women with symptoms. HRT is not appropriate for primary or secondary cardioprotection. HRT leads to a small increase in breast cancer incidence, which increases with duration of therapy and age. HRT increases the risk of thromboembolism. Patient management and therapy should be reviewed annually with risk–benefit counselling.

Rodney J Baber B Pharm, FRACOG, MRCOG · Justine L O'Hara BSc(Biomed Sci) · Frances M Boyle PhD, FRACP

The risk–benefit ratio of traditional postmenopausal hormone therapy is considered by many to be unacceptable. Low-dose oestrogen–progestin therapy (oral or non-oral and continuous or pulsatile) may have a better risk–benefit ratio, but this remains unproven. Steroids with selective tissue activation, such as tibolone, alleviate symptoms and protect against bone loss, but long-term safety data are lacking. Selective oestrogen receptor modulators (SERMs), such as raloxifene, prevent bone loss when used alone, and may soon be combined with oestradiol to treat symptoms and prevent osteoporotic fracture. Effects of SERMs on the cardiovascular system are currently being evaluated.

Susan R Davis FRACP, PhD

Female sexual arousal disorders constitute a varied spectrum of difficulties, ranging from the total absence of genital or subjective pleasurable arousal to feelings of persistent genital arousal in the absence of sexual desire. Arousal disorders can be associated with physical factors (eg, vaginal dryness) or psychological factors (eg, anxiety, distraction), or a combination of both. The most common complaint is the absence of subjective sexual excitement or pleasure despite adequate physical arousal (eg, lubrication). Pharmacological and physical treatments include the use of oestrogen, lubricants and vibrators. There may be a place for drugs that increase vasocongestion and vasodilation. Psychological therapy addresses inhibitions, and interpersonal and motivational factors.

Sandra R Leiblum PhD

In consultations with older women, doctors should ask about sexual problems. A holistic approach is needed to examine the many different factors that can affect sexuality. Hormonal changes associated with ageing have an impact on women's sexuality. Doctors need to have a clear idea of the place of hormonal treatment for different sexual problems. Physical changes associated with ageing, including illness and disability, may interfere with sexual expression. Diseases of the endocrine, vascular and nervous systems will most commonly affect sexual function. A broad range of psychosocial factors associated with ageing may influence sexuality.

Lesley A Yee MB BS(Hons), MM(Psych) · Kendra J Sundquist EdD, MHlth, Sc(Ed)

Health inequalities exist for lesbian and bisexual women, largely related to experiences of discrimination, homophobia and heterosexism. These issues can lead to avoidance of routine healthcare and screening and reduced disclosure of sexual orientation within consultations. Lesbian and bisexual women have specific healthcare needs in areas of sexual and cervical health, reproductive health and parenting, mental health, substance use, and ageing. Facilitation of disclosure of sexual orientation, identity and behaviour within the consultation is desired by most lesbians and important for addressing specific health needs. Healthcare providers should develop "cultural competence" in lesbian issues to enhance their care of lesbian and bisexual women. Healthcare providers have a role in promoting awareness of lesbian health issues and inequalities in the arenas of healthcare provider education, research and health policy.

Ruth P McNair MB BS, DRACOG, DA

Have recent controlled trials ended the debate? Each year in Australia over 10 000 women are diagnosed with breast cancer and around 2600 women die. Early diagnosis improves survival chances. Imagine the following scenario. You have just completed an annual examination of a married, 36-year-old mother of two, when she casually asks: "Doctor, would you recommend that I practise monthly breast self examination?" What do you tell her? What if this patient happened to be a healthy 59-year-old postmenopausal woman, or, for that matter, a "senior citizen" of 81 years, or a woman with a family history of breast cancer? What advice would you proffer? Would you rely on evidence-based data and diplomatically state: "Well, there really is no evidence that breast self examination reduces mortality rates", or would you say "We don't endorse breast self examination, but it would be advisable for you to develop an awareness of your breasts"? What "endpoints" are uppermost in your mind — mortality, detection, even prevention? Perhaps more significantly, what "endpoints" are uppermost in your patient's mind? This is a common dilemma confronting clinicians as they grapple with the vagaries of epidemiology, clinical experience and patients' needs for information and advice. For decades, public health campaigns have targeted women with the message that early detection of breast cancer translates into improved survival chances, and that examination of breasts and mammography are the first steps on the road to early detection. However, following recent trial results,1 those advising women appear to have forgotten this vital relationship between breast self examination, early detection and consequent improved survival. "Detection" has become the "poor cousin" of survival, mortality, and the teaching and practice of breast self examination. The result is confusion, ambivalence and, at times, contradictory or nonsensical advice. This is clearly reflected in the various statements promulgated by Australian cancer organisations, which now tread very carefully when using those three, once so helpful, words, "breast self examination". BreastScreen NSW has dropped them from its recommendations and state cancer councils, the National Breast Cancer Centre and the NSW Breast Cancer Institute are in the process of doing same, or are carefully rephrasing them to being simply "breast self aware". As an example, The Cancer Council NSW Fact Sheet2 recommends gaining awareness "by looking at your breasts in the mirror and feeling them from time to time". This sounds pretty much like self examination of breasts to us, only without the previous instructions on how to do it effectively. The Fact Sheet sensibly continues "some women feel that regular breast self examination is worthwhile. It's up to you". Advice from other cancer organisations contains similar hedging statements. These messages reflect the difficulty of interpreting evidence-based data derived from studies with differing endpoints — both for the clinical situation and for the commonsense advice sought by women. The National Breast Cancer Centre's position statement is largely based on the comprehensive 1999 literature review of studies of breast self examination by Clarke et al.3 Of considerable significance are the methodological shortcomings of those studies and their diversity of endpoints. But most compelling is that, of the seven trials reported, none provided National Health and Medical Research Council Level I evidence, two gave Level II and the others Level III — not overly convincing! In 2002, the eagerly awaited final report of the trial by Thomas et al1 became available. Despite the fact that Thomas and colleagues concluded that this was a trial of the teaching of breast self examination (ie, the specific technique), not the practice of breast self examination (nor, indeed, a trial of the breast examination that many aware women do whether or not they are trained in the "breast self examination" technique), the editorial in the Journal of the National Cancer Institute trumpeted the study's results as signalling the "death" of breast self examination.4 An editorial in the British Medical Journal 5 claimed that Thomas and colleagues had provided "conclusive" evidence that breast self examination was not effective in reducing mortality, and concluded that the study should put an end to a decade of controversy. We believe that this statement is most unhelpful and could lead to delayed detection of breast cancer, particularly in younger women, for whom mammography is less effective.6,7 While acknowledging that this was the largest trial ever conducted on the relationship between breast self examination and mortality from breast cancer, how transferable are results from women in Shanghai to women in Australia? A growing body of literature8-10 casts some doubt on the universality of the findings of Thomas and colleagues, as cultural context and associated values and behaviours were ignored. Potential confounding factors, such as attitudes towards breast self examination and healthcare, were not investigated. The position of the Breast Cancer Action Group (NSW and VIC) is the commonsense approach — that women should be physically familiar with their breasts and seek advice if they notice any non-normal changes. If you feel a lump or notice other changes — and how else can this be done other than by physically examining the breasts? — take the next step on the triple-test path of mammography, ultrasound examination and biopsy. Further concerns in this debate relate to the suggestion that encouraging awareness of breast changes will distress women, and will possibly increase the health dollars spent on unnecessary investigation. The first claim is patronising, even demeaning, and the second runs counter to the evidence-based public commitment to increase screening modalities for Australian women. What is indisputable for Australian women is that breast examination is the predominant method of detecting breast cancer. In Australia, mammographic screening accounts for just over 30% of detected breast cancers (37% of early disease, 14% of advanced disease);11 the remainder are found by women themselves and their medical advisers. How are they found? By examining their breasts! For younger women this is usually the only avenue for detection — early or late — as clinicians rarely offer clinical breast examination, and mammography is not effective. Our research priority in this area would be for careful and well designed studies of the relationship between breast self examination and early diagnosis. What interests us is increased early detection, whether this be via breast self examination, mammography, or ultrasound examination. It is imperative that clear and unambiguous messages are transmitted to give women the best chance of survival. Resorting to the semantics of "being breast aware" fails this imperative. Common sense suggests that it is not possible for us to somehow be "breast aware" without examining them.

Sally Crossing BEc · Rosetta Manaszewicz

Vaccination has the potential to reduce the global burden of disease from genital HPV infection Cervical cancer is the third most common cancer worldwide and, for women, the second most common after breast cancer. Each year there are about 466 000 new cases globally, and around 232 000 women die of cervical cancer.1 Eighty per cent of cases occur in developing countries, where it is the leading cause of cancer-related death among women.1 Precursor lesions (high-grade dysplasias) precede the development of cancer by years. With appropriate screening programs and early diagnosis and treatment, this reproductive health problem becomes a preventable public health issue. However, data for the past 5 years indicate that only about 5% of women in developing countries are screened, compared with 40%–50% of women in developed countries. Further, because of the insensitivity of the Papanicolaou (Pap) test, even in countries with appropriate screening programs, 50% of adenocarcinomas and at least 25% of squamous cell carcinomas occur in adequately screened women. Association between human papillomavirus and cervical cancerMolecular biology has finally established the causal association between persistent infection with certain human papillomavirus (HPV) genotypes and cervical cancer, supporting previous observations relating cervical cancer to sexual activity.2-4 HPV genotypes 16 and 18 are now categorised as human carcinogens,2 and it is noteworthy that these two HPVs are present in over 70% of cases of cervical cancer worldwide.2-4 Further, in a study of almost 1000 cervical cancer cases worldwide, the prevalence of HPV infection was 99.7%.3 Recently, less prevalent oncogenic HPV genotypes (31, 33, 45, 52, 58, 59) have also been found to be strongly associated with cervical cancer, with odds ratios several hundredfold.4 With such high relative risks, the association between persistent oncogenic HPVs and cervical cancer is the strongest for any environmental factor and human cancer. From recently completed longitudinal studies, we now know that genital HPVs are the commonest sexually transmitted viral infection. They are largely transient, usually asymptomatic and most are of no clinical consequence. The mean duration of carriage is 4 months for low-risk oncogenic types and 8 months for high-risk oncogenic types, with HPV-16 carriage being even longer.5 Genital warts are caused by genotypes 6 and 11 (low-risk HPVs), while persistent infection with oncogenic genotypes (over years and in a minority of patients) results in severe dysplasia or, ultimately, carcinogenesis. This process involves other cofactors (host and/or exogenous factors, such as high parity, cigarette smoking) and complex pathways, which are not completely understood. HPV DNA as a marker for precursor lesionsPersistent infection with oncogenic HPVs precedes virtually all high-grade dysplasias or neoplasias. Thus, persistent positivity for high-risk HPV DNA is a marker for current or subsequent development of precursor lesions,5 with persistent HPV DNA type-specificity being an even stronger predictive factor.6 Cohort analyses show that negative baseline Pap and HPV DNA tests are associated with very low risks of high-grade disease (0.16%). By comparison, women with positive HPV DNA tests and abnormal Pap smear results have a 4.54% cumulative incidence of high-grade dysplasia or cancer.7 HPV DNA testing, with its higher sensitivity for detecting underlying high-grade lesions than the Pap test (and the advantage that it can be performed on self-collected samples), is being reviewed for its clinical utility, either in triage of inconclusive or minimally abnormal smears, in conjunction with the Pap test, or as a stand-alone test in primary screening.5 It may also have a role as a test of cure after ablation for cervical dysplasia; persistence of HPV DNA after treatment could be an accurate predictor of residual disease or relapse.5 Of note, in the United States, HPV DNA (Hybrid Capture 2) testing was recently approved for use with the Pap test for women 30 years and over.8 Vaccination prevention at last?The preliminary results of a recent trial of a monovalent HPV genotype 16 vaccine were received with great interest and enthusiasm (Box). The vaccine provided vaccinees with high-level protection for incident and persistent HPV-16 infection (as a surrogate for invasive cancer) and HPV-16-related cervical intraepithelial neoplasia (CIN).9 Now awaited are larger studies to prove that clinical disease is prevented by vaccination, and the results of current clinical trials evaluating multivalent vaccines (HPV types 6, 11, 16 and 18). If these vaccines are as successful as the interim monovalent vaccine,9 they have the potential to prevent genital warts and over 70% of dysplasias and cancers, as well as reduce the occurrence of abnormal Pap smear results and the costs of their follow-up and management. Pivotal in the development of these vaccines was the production of virus-like particles (VLPs) — an Australian first.10 The VLPs used for the HPV-16 vaccine are viral subunits, composed of the major capsid protein L1 or outer shell of HPVs. Being devoid of DNA, they are not infectious. In Phase 1 and 2 clinical trials, VLPs have been shown to be not only immunogenic and safe, but able to induce strong cell-mediated and humoral immune responses. Most encouraging is that VLPs produce neutralising antibodies in animal models that are protective against challenge as well as long lasting. We need to see whether VLPs induce similar long-lasting immunity in humans. Second-generation vaccinesSecond-generation vaccines will need to be easier and cheaper to develop, give a broader coverage, have a better delivery system, allow better mucosal delivery, and possibly incorporate both prophylactic and therapeutic cover. The initiatives of the Gates Foundation to reduce cervical cancer in developing countries, where the disease is most common, are to be commended.11 Initiatives to promote second-generation vaccines (eg, vaccines that are cheaper to manufacture and available in a non-injectable form) have been discussed at a meeting of HPV vaccine experts, convened by the Gates Foundation in Seattle, Washington, in September 2002. Therapeutic vaccines have been successful in animal models, and there have been various Phase I and II trials in humans using HPV subunits (modified fragments of the HPV E6 and E7 genes), as well as chimeric and DNA viral approaches.12 These trials have shown some encouraging results for intraepithelial neoplasias, although clinical trials are not as advanced as for the prophylactic vaccines. An important question for vaccine development is whether there will be any cross-protection between types (immunity induced by natural infection is type specific), or whether effective vaccine-induced immune responses to one common high-risk HPV might simply open the door to another, currently less common type. In Australia, mortality from cervical cancer has been reduced substantially by an effective Pap screening program, but this comes at a considerable cost, both to the health budget and to women who face the psychological impact of having an abnormal Pap smear result. Ultimately, successful vaccination has the greatest potential to reduce the global burden of disease from genital HPV infection. Development of a vaccine for a sexually transmitted infection, the infective agent of which can not be grown by traditional methods in the laboratory, could be seen as a very important breakthrough, particularly for Australia (as VLPs were developed here).10 An effective prophylactic vaccine could ultimately obviate the need for population-based Pap smears, while an effective therapeutic vaccine could provide a change to conventional management of cervical disease, including reducing the need for colposcopy. However, lowering the incidence of dysplasia and neoplasia will take many years. In the meantime, the various prevention strategies still need to be endorsed and maintained. Apart from cervical cancer, other anogenital cancers and some non-melanoma skin cancers are also attributed to oncogenic HPVs. A successful vaccine could ultimately have an even greater impact on HPV-related diseases. Other challengesBesides vaccine delivery, vaccine implementation would include educating the general public about HPV (public awareness and acceptance), de-stigmatising HPV infection, and gaining acceptance for vaccinating adolescents (or pre-adolescents), possibly of both sexes, for a sexually transmitted infection before their sexual début. For the future, we need a better understanding of the transmission dynamics of HPV. A public health policy will need to be guided by mathematical modelling of the impact of an HPV vaccine on Pap screening. This also applies to the interrelationship between HPV and abnormal Pap smear results, and any concomitant psychological impact on women faced with an abnormal result of an HPV DNA test or a Pap smear. A controlled trial of a human papillomavirus (HPV) type 16 vaccine, by Koutsky et al9 Study population: 2392 young women, 16–23 years old (no more than five male sexual partners during their lifetime). Intervention: Intramuscular vaccination with three doses of placebo or HPV-16 virus-like particle (VLP) vaccine (Day 0, Month 2, Month 6). Follow-up: Month 7, 12 and thereafter 6 monthly to 48 months (Pap test, and HPV DNA 16 and HPV-16 antibody assayed). Colposcopy biopsy tissue evaluated for cervical intraepithelial neoplasia (CIN). Primary endpoints: Persistent HPV-16 infection (the detection of HPV-16 DNA in samples obtained at two or more visits ≥ 4 months apart, in those HPV DNA negative at Day 0 and Month 7) and HPV-16-related CIN. Results: After a median follow-up of 17.4 months, the incidence of persistent HPV-16 infection was 3.8/100 woman-years (placebo group) and 0/100 woman-years (vaccine group) (100% efficacy; 95% CI, 90–100; P < 0.001). Nine cases of HPV-16-related CIN occurred, all in the placebo group. 99.7% of the women vaccinated seroconverted and with a robust antibody response. Conclusion: HPV-16 vaccine reduced the incidence of both HPV-16 infection and HPV-16-related CIN. The study is continuing.

Suzanne M Garland FRCPA, FACSHP, RANZCOG ad eund, MD

Achieving and maintaining a high rate of attendance for screening and two-yearly re-screening is essential for the success of the BreastScreen Australia program. A low participation rate will result in fewer breast cancer-related deaths being prevented. Results of two recent large randomised trials do not show that a systematic approach to breast self examination finds breast cancers early or impacts on survival. "Breast awareness" and the prompt reporting of breast symptoms are important early detection messages for women of all ages. General practitioners have a key role in the promotion and provision of information about effective public-health initiatives for the early detection of breast cancer.

Helen M Zorbas MB BS

Cervical screening in Australia is a successful public health initiative. Since the introduction of the National Cervical Screening Program in 1991, there has been a significant fall in incidence of and mortality from cervical cancer. Laboratory quality procedures are critical to ensuring optimal outcomes. Laboratory accreditation procedures are being reviewed in line with recent government recommendations. For a sustainable program, cost-containment issues need to be considered; screening interval, management of screen-detected abnormalities, and new technologies are the critical drivers of cost.

Annabelle Farnsworth FRCPA, FIAC · Heather S Mitchell FRACP, FAFPHM

Ovarian cancer is the leading cause of death from gynaecological malignancies. No precancerous lesions have been identified. Bimanual examination has not been proven to be of value as a screening test. Transvaginal ultrasound examination, with or without measurement of CA 125 levels, is currently being evaluated for population screening. Women at high risk of ovarian cancer should be screened annually — with measurement of CA 125 level and transvaginal ultrasound examination.

Cleola Anderiesz PhD · Michael A Quinn MGO, FRANZCOG, FRCOG

Routine screening for endometrial carcinoma is currently not justified. Postmenopausal women need to be educated about the importance of seeking attention if any vaginal bleeding occurs. All postmenopausal bleeding requires review and appropriate investigation. Women taking tamoxifen have a higher risk of endometrial cancer and should report any bleeding or spotting; however, ultrasound screening is not recommended for asymptomatic women taking tamoxifen. Families with hereditary non-polyposis colon cancer have a higher risk of endometrial cancer and require counselling about this risk. A Pap test is not a screening test for endometrial cancer, but the incidental finding of endometrial cells on a Pap smear in a postmenopausal woman requires investigation.

Gregory Robertson FRCOG, FRANZCOG, CGO

This 19th century US gynaecologist still arouses controversy in the 21st century To the indomitable courage of these long-suffering women, more than to any one other single circumstance, is the world indebted for the results of these persevering efforts. J Marion Sims, 18581 "Pass me the Sims" is a request heard every day during gynaecological surgery and as often in outpatient practice. The Sims speculum has been a valuable gynaecological aid throughout the world since the first example was crudely fashioned from a pewter spoon in 1845 by James Marion Sims, a general practitioner in Montgomery, Alabama.2 Sims went on to perfect the instrument that, with little variation, is still widely used in most vaginal surgery and for outpatient assessment of cervical and vaginal conditions, especially prolapse and fistulas. "Sims' position" or the exaggerated left lateral position was devised a little later, as Sims experimented with the repair of vesicovaginal fistula in a small hospital he built for black women slaves with this condition. It is also widely used in surgery and examination today. In the United States, Sims has often been referred to, rather quaintly, as the "Father of Gynaecology"; certainly, he was one of those who developed gynaecology as a separate medical discipline.3 His statue stands in Central Park in New York (Box 1). However, in the latter part of the 20th century, the earlier idealistic views of Sims have been challenged by feminist writers and social historians.4-6 He experimented with women's bodies, these writers have said, in particular those of women slaves, and he did not use anaesthesia. While these criticisms are valid, I believe they warrant further examination. Sims and fistula repairSims was born in South Carolina in 1813 and studied medicine (indifferently, according to many biographers) at Charleston and later at Jefferson Medical College in Philadelphia.7-9 He returned to the South to practise and soon established a reputation as a skilful surgeon. He became interested in the condition of vesicovaginal fistula in 1845 when a young slave woman, known to posterity only as Anarcha, developed a fistula after a prolonged first labour. Until then, Sims had had little interest in "women's problems". Surprisingly, within days, two more slaves with this condition, Betsey and Lucy, were referred by their owners. Scanning the available literature on fistula repair, Sims determined that there was no surgical cure and decided not to operate.2,3,7,9 However, another event that occurred within days changed his mind.7 He was summoned to a Mrs Merrill — a stout lady who had fallen from a pony and landed heavily on her pelvis, suffering an acutely painful retroversion of the uterus. Uncertain what to do, Sims placed her in the knee–chest position and in the course of his subsequent digital examination applied firm pressure to her perineum, allowing a large amount of air to enter the vagina. This vaginal distension together with the exaggerated knee–chest position caused the uterus to return to its anteverted state.2,3,7 As Pasteur would later observe, chance favours the prepared mind: Sims reasoned that a speculum that holds back the perineum, unlike the two- or three-pronged intravaginal models then in use, would similarly expose the upper reaches of the vagina, the site of vesicovaginal fistulas.9 This realisation led Sims to purchase a pewter spoon from a hardware store in Montgomery and to bend it into a U shape (Box 2). The following day, he examined Betsey in the knee–chest position with the bent spoon. Subsequently, he wrote: I saw everything, as no man had ever seen before. The fistula was as plain as the nose on a man's face. The edges were clear, and well-defined . . . and the opening could be measured as accurately as if it had been cut out of a piece of plain paper . . . I said at once, Why can these things not be cured . . . there is nothing to do but to pare the edges of the fistula and bring it together nicely, introduce a catheter in the neck of the bladder and drain the urine off continually, and the case will be cured. I felt I was on the eve of one of the greatest discoveries of the day.7 In fact, Sims penned this florid prose long after these events, in The story of my life, when he was well established as a gynaecologist in New York and Europe. Never short on self confidence, he was much given to embellishment and flowing narrative in his later accounts of his work. However, although Sims did give fascinating descriptions of his achievements, he did not spare himself in describing his failures.3,7,9,10 Sims had specula and other instruments made and deliberately set out to cure fistulas. Initially, he continued to use his specula with the woman in an exaggerated knee–chest position, which is excruciatingly uncomfortable for any length of time. Later he realised that the exaggerated left lateral position afforded a better view of the upper and anterior vagina, and this became the position in which he continued surgical experiments (Box 2), and in which established procedures were henceforth performed.7,11 In his autobiography, Sims explains that slaves (the original three and others) were subject to numerous attempts at closing their fistulas — without anaesthesia (which was not then widely available). Opium was administered during and after the procedures (Box 3). Sims claimed that he explained his intentions to the women, who were agreeable. He did not question the racial and social system that made his experiments possible, although in his later writing he did express concern for the welfare of the women involved. He also stated that the "stoicism of the Negro" made it possible for him to continue his surgical experiments — some 30 operations over four years on Anarcha before her fistula was successfully closed. His first operation, on Lucy, was particularly agonising for her, as he had not yet developed the catheter that he subsequently used for the bladder drainage essential for the success of any fistula repair. He used instead a piece of sponge which became infected and encrusted and difficult to remove.2,7 Initially, Sims used silk to close the fistulous openings, but healing was never complete. Finally in 1849, he tried silver wire held with perforated lead shot which, when compressed in a pair of forceps, enabled the sutures to be tied high in the vagina.9 Anarcha's fistula was closed permanently (according to Sims), and soon afterwards those of the other women.1,12 Subsequent writers have cast doubt on Sims' claims of complete cure, and it may be that, although the fistulous opening was healed, bladder function remained compromised — even after modern fistula surgery, stress and urge incontinence can be problems.12-15 However, there is no doubt that Sims had made great progress in the understanding and techniques of fistula repair (Box 4). In 1850, Sims, suffering poor health, moved to New York with the idea of founding a women's hospital for the treatment of vesicovaginal fistula and, later, other gynaecological ailments. The New York Woman's Hospital opened its doors on Madison Avenue in 1855, later moving to the current site of the Waldorf–Astoria.2 However, the hospital opened only after a great deal of interpersonal wrangling with certain New York doctors and financial difficulties for Sims; nevertheless, he persevered with his unique idea. Many poor Irish immigrant women were among those treated for fistulas at the Woman's Hospital, as Sims and other surgeons perfected fistula repair and other operations.2,7,9,18 During the 1860s, Sims went several times to Europe, partly because of his unhappiness at the political events that culminated in the Civil War, and partly to demonstrate his surgical techniques. There is no doubting his surgical brilliance, which he displayed throughout the British Isles and in Paris. He treated European royalty, including the Empress Eugenie, wife of Napoleon III of France, who apparently had suffered an obstetric fistula. During the Franco–Prussian war of 1870, Sims took part in the Anglo–American Ambulance Corps, which treated the wounded of both sides.7 Returning to the United States, he became president of the American Medical Association in 1876, and founder and then president of the American Gynaecological Association. In defence of SimsIt is not surprising that the idealistic view of Sims has been challenged,4-6 given his turbulent life and self-promotion. It is true that his initial experiments on fistula repair were on slave women, and that he did not use anaesthesia. However, other factors must be considered. Firstly, the nature of vesicovaginal fistula itself — without surgery, these women were condemned to the most miserable existence. Better understanding of labour and avoidance of a prolonged second stage by operative delivery means that obstetric fistulas rarely occur in countries with good obstetric services, and modern writers with no experience of the condition have tended to overlook the appalling results of fistulas.4-6 "A sadder situation can hardly exist than that of a woman afflicted with a vesico-vaginal fistula", wrote Johann Friedrich Dieffenbach in 1836, "a source of disgust, even to herself, the woman beloved by her husband becomes, in this condition, the object of bodily revulsion to him . . .".10 Dieffenbach's concern for women with fistulas was shared in the late 20th century by Drs Reginald and Catherine Hamlin, who founded the famous Ethiopian Addis Ababa Fistula Hospital, and Dr Kees Waaldijk, who has established a similar service in northern Nigeria; "these patients are the forgotten women, rejected by their husbands and sometimes by their families because their bodies have suffered excessive trauma during childbirth", Waaldijk has said.14,19 More than 150 years after Sims' first successful repairs, more than two million women in the world suffer from obstetric fistulas, a preventable condition. Most are in resource-poor countries, especially in Africa, parts of Asia and Papua New Guinea, where antenatal and intrapartum care are minimal or non-existent, and where early childbearing and poor nutrition contribute, as in the pre-Civil War southern United States, to the development of fistulas. Although Sims recognised the obstetric causes of fistulas, he lived in an era that preceded the safe use of caesarean section, synthetic oxytocic drugs, antibiotics and the many other aids to safe childbirth that are now available. He was not in a position to prevent the formation of the fistulas he attempted to treat. Partly because of the path Sims' life followed and because of his writings, some historians have accused Sims of being motivated principally by a desire to experiment on black women with a view to later treating wealthy white women.4-6 However, as a young man living in the deep South and treating black women with a condition largely associated with their poverty, Sims could not have anticipated the later course of his life or expected that fistula repair would make him competent in the practice of gynaecology, a specialty that did not exist in the 1840s. Hideous as the accounts of his surgery may appear to sensitive 20th century eyes, undoubtedly Sims was at least partly motivated by a desire to improve the lot of his slave patients.2,7 In this, he was no different from many 19th century surgeons experimenting with the techniques that are the foundation of current surgical practice, gynaecological and otherwise. The lives of the slave women on whom Sims experimented would have been even more miserable without their subsequent cures, and the knowledge gained has been applied to fistula repair for thousands of women since. Secondly, Sims did not use anaesthesia for his early fistula repairs because it was not yet widely available. Humphry Davy had discovered the anaesthetic properties of nitrous oxide in 1799, but its usefulness for surgery was not immediately appreciated. Sulfuric ether was first used by Crawford Long in Georgia in 1842, but he did not write about his discovery until 1849. By the early 1840s, a small number of doctors and dentists knew of the existence of anaesthetic agents, but the idea that they could be safely used to numb the pain of surgery, like the concept of antisepsis some time later, took years to be universally accepted. In 1845, Horace Wells unsuccessfully demonstrated anaesthesia for dentistry; in 1846, William Morton in Boston was more successful. The Lancet of 1845 carried only five short mentions of ether in 780 pages, and, as late as 1850, when James Young Simpson published his recommendations for the use of ether and chloroform in midwifery, he had to contend with vociferous opposition from clergymen who pronounced anaesthesia to be against the will of God.20,21 It is then not surprising that Sims in Alabama in the 1840s did not anaesthetise his patients. Certainly all previous attempts at fistula repair, like virtually all other surgery, on free white people as well as slaves, had been done without anaesthesia. Later in New York, Sims did use chloroform, which he pronounced "both delicious and dangerous".7 Interestingly, Sims was remarkable for his attention to cleanliness in his surgery, well before the advent of Listerism, which probably contributed to his ultimate surgical success. Sims' role in the development of gynaecology is incontestable, but in remembering his contribution to vesicovaginal fistula repair the names of Anarcha, Betsey and Lucy should also be remembered. Others of his contributions are remembered daily by every generation of gynaecologists — the Sims' speculum and Sims' position. 1: Statue of Sims in Central Park, New York The statue was sculpted by Ferdinand von Miller III and installed elsewhere in New York in 1892, before being moved to Central Park in 1934. 2: Sims' speculum and Sims' position (From Sims' original text, Silver sutures in surgery, 1858.1) 3: The fistula operation on Betsey An original painting by Robert Thom depicting the event with some artistic licence 100 years later (commissioned by the Parke–Davis Company, from A history of medicine in pictures, edited by Bender GA, 1961). 4: Fistula repairs before Sims Sims was not the first to repair vesicovaginal fistulas successfully. There are some reports of European surgeons doing so. In 1836, John Peter Mettauer in Virginia and, in 1839, George Hayward in Massachusetts succeeded in closing fistulas. Twenty-five years before Sims' experiments, Montague Gosset in England had used silver wire in a fistula repair, and the use of lead shot to hold wire sutures in place was also known.1,16,17 However, what Sims did do was to combine and apply all these principles systematically, with skill and persistence, and to publicise his techniques.

Caroline M de Costa FRANZCOG, MPH

In this issue of the Journal, Priest and colleagues report a further study showing the lack of effectiveness of "debriefing" after a traumatic event in preventing psychological disorders — in this case, in women after childbirth.1 Their use of debriefing for this purpose indicates how widely the enthusiasm for this intervention has spread in the past decade. On superficial examination, early interventions are an appealing ...

Alexander C McFarlane MD, DipPsychother, FRANZCP

Objective: To test whether critical incident stress debriefing after childbirth reduces the incidence of postnatal psychological disorders.Design: Randomised single-blind controlled trial stratified for parity and delivery mode.Setting: Two large maternity hospitals in Perth.Participants: 1745 women who delivered healthy term infants between April 1996 and December 1997 (875 allocated to intervention and 870 to control group).Intervention: An individual, ...

Susan R Priest M Psych, PhD · Jenni Henderson BSc, MPH · Sharon F Evans MSc, PhD · Ronald Hagan MB BCh, MBA

To the Editor: Chlamydial infection is the most common bacterial sexually transmitted infection in Victoria and Australia, and notifications are increasing significantly. Most chlamydial infections are asymptomatic and, if untreated, lead to significant morbidity.1 The direct costs of these infections to the Australian healthcare system have been estimated at $90–$160 million annually.2 Chlamydial infection has been implicated in as many as 50% of cases of infertility.3 Widespread screening is cost effective and reduces both the prevalence of infection and the rate of complications.4 Screening is recommended in a number of countries and in the recently released Victorian Chlamydia Strategy.2 To determine if there has been an increase in the proportion of women tested for chlamydial infection who are asymptomatic in Victoria, we analysed notification and enhanced surveillance data. Since 1997, the Department of Human Services has collected enhanced surveillance data using a standard questionnaire distributed by laboratories to clinicians. The forms record information on risk factors and the reason for testing. Data from the Health Insurance Commission were obtained to provide an indication of trends in testing through Medicare. The number of notifications almost doubled between 1997 and 2001, from 2059 to 3977 notifications (Box). In 2001, enhanced surveillance data were available on 2300 notifications (58%). Symptomatic presentation remained the major reason for testing (53%), with no significant change in the proportion tested for this reason since 1997. However, when data for the two sexes were analysed separately, the proportion of men who were symptomatic fell significantly between 1997 and 2001, from 77% to 65% (P = 0.02), while there was no change in the proportion of women who were symptomatic — 42% in 1997 and 41% in 2001 (P = 0.35) (Box). From 1997 to 2001, the number of positive chlamydial tests notified relative to the number of tests conducted has remained constant (9.7%, 8.8%, 11.8%, 11.5% and 9.8% in consecutive years, respectively), despite the increase in number of tests performed. However, even if all tests had been performed in the 20–30-year-old age group, they would represent only 10% of the population in that age group tested each year. Our data suggest that the reasons for testing over the past 5 years have not changed, and, in particular, that there has been no change in the proportion of women tested who are asymptomatic. Chlamydial infection meets the World Health Organization criteria for a screening program,5 and screening for this infection is cost effective.4 Although chlamydial infections are a significant public health concern for women, targeted screening is not occurring widely. Chlamydia notifications and enhanced surveillance data for Victoria, 1997–2001 1997 1998 1999 2000 2001 Male Female Male Female Male Female Male Female Male Female Number of notifications 788 1271 948 1542 1181 1761 1328 1915 1631 2346 Number with enhanced surveillance data 484 782 619 954 735 968 858 1037 992 1308 Reasons for testing* Symptomatic 76.9% 42.3% 75.8% 46.0% 73.9% 44.1% 68.6% 39.4% 64.9% 41.1% STI Screen 7.2% 25.4% 6.5% 25.6% 9.0% 26.3% 9.8% 27.2% 12.3% 27.2% Asymptomatic contact 13.8% 15.5% 16.2% 17.5% 15.8% 18.7% 18.1% 16.9% 18.9% 17.4% Abnormal examination 0.2% 3.2% 0.6% 3.8% 0.7% 4.0% 0.2% 1.6% 0.8% 2.3% Pre-termination screen 0 9.3% 0 5.5% 0 5.6% 0 5.6% 0 3.7% Other/not stated 1.9% 4.3% 0.9% 1.7% 0.6% 1.2% 3.2% 9.3% 3.1% 8.4% Total notifications 2059 2490 2942 3243 3977 STI = sexually transmitted infection. * Mutually exclusive choices presented to clinicians in the surveillance questionnaire.

Megan L Counahan · Jane S Hocking · Christopher K Fairley