Women's health

To the Editor: Self‐collected vaginal samples are as effective as clinician‐collected cervical samples for detecting underlying cervical intraepithelial neoplasia grade 2 or higher (the target lesion of cervical screening) using polymerase chain reaction‐based oncogenic human papillomavirus DNA assays.1 However, the use of self‐collection within Australia’s cervical screening program is currently restricted to women who are underscreened or never screened (at least 2 years overdue, so 4 years since their last Pap test), aged ≥ 30 years and refuse a clinician‐collected sample. This is because, at the time the current policy was developed, self‐collection was believed to result in a small loss of sensitivity. Accredited laboratories are not permitted to test samples that do not meet these requirements. VCS Pathology (part of the Australian Centre for the Prevention of Cervical Cancer) was the first laboratory to receive regulatory approval to process self‐collected samples. Here we report the reasons for rejection of samples received between February 2018 and 30 June 2021, which is important given that about one‐third (34%; 2166/6234) of samples received could not be processed (37.4% in 2018; 37.9% in 2019; 34.1% in 2020; 22.8% in 2021). The three most common reasons were that the person was not sufficiently overdue (54.1% of rejected samples; 18.5% of all samples); that the wrong type of collection device was used (17.3% of rejected samples; 5.9% of all samples); or that the person was < 30 years of age (11.2% of rejected samples; 3.8% of all samples). Other reasons included delayed sample receipt (5.2% of rejected samples; 1.8% of all samples), presence of symptoms (3.0% of rejected samples; 1.0% of all samples) and multiple reasons (combination of above factors: 6.6% of rejected samples; 2.3% of all samples) (Box). The implementation of self‐collection, while known to be highly acceptable to many women who will not accept a speculum examination for screening,1,2 has been problematic in Australia to date.3,4 The eligibility restrictions and strict laboratory requirements have created unintended barriers for practitioners and potential participants, as demonstrated by both the sample rejection rate and low overall numbers compared with the eligible population (< 1%).3 The recently announced mainstreaming of self‐collection, by making it a choice for all screening participants using on‐label tests, should overcome many of these barriers5 and improve program equity and participation. Successful implementation will depend on timely education, communication and change management. Box – Proportion of 6234 self‐collected samples received that were unable to be processed, by reason and year of receipt (VCS Pathology, February 2018 to the end of June 2021) * Incorrect collection device refers to wrong swab type or media. † Other reasons include duplicate samples, and pregnancy (which was initially an exclusion criterion).

Julia ML Brotherton · David Hawkes · Marion Saville

To the Editor: In March 2021, the federal Parliament introduced a bill to legalise the use of the reproductive technology known as mitochondrial donation in Australia.1 Mitochondrial donation would be offered initially at a single trial clinic and, eventually, it would be made more widely available. The aim is to provide at‐risk women with the opportunity to have a genetically related child who is unlikely to develop maternally inherited mitochondrial disease. Legalising mitochondrial donation would have meaningful benefits for such women. However, as the bill currently stands, its implementation raises unresolved ethical and legal issues. Access will predictably be mediated by geographic, financial, medical and informational considerations. These include the location of the initial trial clinic, any out‐of‐pocket costs to prospective parents, and health professionals’ awareness of mitochondrial donation. Existing barriers to genomic testing, genetic counselling, and assisted reproductive technologies will also affect access. These barriers, including long waiting times and limited Medicare coverage for some genetic services, should be minimised. Mitochondrial donation requires donor oocytes. This raises questions about how oocytes will be procured and how many should be apportioned to mitochondrial donation relative to other procedures that may require fewer eggs to achieve a live birth. One crucial issue is whether oocyte donation for mitochondrial donation should require specific consent from donors. One option is to use oocytes donated for assisted reproduction generally, without requiring consent for their use in mitochondrial donation specifically. The first study of mitochondrial donation to yield a live birth took this approach.2 However, we believe this strategy fails to acknowledge the legitimate reservations some donors may have about the use of their oocytes in this novel reproductive procedure. Securing specific informed consent would protect donors’ wellbeing and autonomy as well as protect public trust in medicine. At a minimum, specific consent should be required in the trial stage. This could also generate important data on the views of a critical group of stakeholders (the oocyte donors) and on what impact, if any, requiring specific consent would have on oocyte supply. Mitochondrial donation also prompts a reconsideration of the ethics of sex selection. The Australian Government has signalled that it may provide parents with the option of implanting only male embryos.3 Since mitochondrial DNA is inherited through the maternal line, this would minimise any effects on the descendants of children born via this technique. However, this use of sex selection sits uneasily with Australia’s legal prohibition on, and moral reservations regarding, non‐medical sex selection. Both male and female embryos would receive identical mitochondrial DNA and face the same risks from the procedure; sex selection reduces risks only to that child’s descendants. There is also a concern that offering sex selection would lead parents to believe it is medically indicated, creating a sense of pressure to select male embryos. As sex selection raises serious concerns without promising clear benefits, we think there are problems with offering it in this context. Legalising mitochondrial donation raises numerous ethical issues, including access, oocyte donor consent, and sex selection. While mitochondrial donation carries important potential benefits, these issues need careful attention to ensure that its implementation in Australia is ethically robust.

Julian Koplin · Esther Lestrell

Functional hypothalamic amenorrhoea is common but often misdiagnosed, risking inappropriate management and compromised patient education and counselling

Elisabeth Ng · Shoshana Sztal‐Mazer · Susan R Davis

To the Editor: The Standing Committee on Social Policy and Legal Affairs recently completed its inquiry and final report into family, domestic and sexual violence in Australia.1 This comprehensive report made 88 recommendations to inform Australia’s next National Plan to Reduce Violence Against Women and their Children (National Plan). The report explores violence victimisation in diverse communities (eg, Indigenous people, people with a disability). However, consideration of women involved in the criminal justice system is conspicuously absent. Many women involved in the criminal justice system are victim‐survivors of family, domestic and sexual violence. Estimates suggest that between 70% and 90% of women in prison in Australia have been victims of violence.2 In addition, our previous research found that women released from prison are 16 times more likely to die from violence compared with women of the same age in the Australian population.3 However, the only mention of women involved in the criminal justice system as victim‐survivors in the report is in the subsection discussing Indigenous people which acknowledges that Indigenous women experience disproportionate levels of violence victimisation and incarceration. While Indigenous women should be a priority group for violence prevention, and are over‐represented in prisons in Australia, this was a critical missed opportunity to address the over‐representation of victim‐survivors in the criminal justice system. For many Indigenous and non‐Indigenous women, their offending is connected to previous experiences of violence victimisation.2 Victim‐survivors are also being funnelled into the criminal justice system due to inappropriate criminal justice responses to family and domestic violence.4 As noted in the report, the current National Plan (2010–2022)5 has not been successful in reducing violence against women, and as such, this type of violence remains a prominent and all too common issue in Australia. Women involved in the criminal justice system should be among the priority groups for national violence prevention strategies. The next National Plan should address the health and social needs of these women, which are often drivers of both criminal justice involvement and violence victimisation (eg, mental health, housing, financial independence). Trauma‐informed criminal justice responses that recognise the impact of traumatic experiences on health and behaviour, such as pre‐arrest diversion to mental health or family violence services,6 are also needed. Without this, women who are victim‐survivors of violence will continue to be criminalised due to a misunderstanding of the impacts of family, domestic and sexual violence on their health, lives and behaviour.

Melissa Willoughby · Stuart A Kinner

To the Editor: The average woman giving birth in Australia has ten to 12 antenatal visits and a 2–4 days inpatient stay, representing 8 months of intense engagement with health services. In 2020, women in Melbourne endured a prolonged lockdown period due to the coronavirus disease 2019 (COVID‐19) pandemic.1 During this time, the maternity sector had to move quickly to address three urgent priorities. Firstly, all 12 public maternity hospitals in Melbourne joined forces to create the Collaborative Maternity and Newborn Dashboard for the COVID‐19 pandemic (CoMaND) to meet the need for timely perinatal data collection.2 By harnessing hospital maternity data collection systems under a research protocol, they could centrally monitor perinatal outcomes to assess indirect impacts of the sector’s pandemic response (Box). The second of the priorities was to institute a system to record outcomes for women who were infected with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) during pregnancy. To this end, the Coronavirus Health Outcomes in Pregnancy and Newborns (CHOPAN) registry was established. It has collected information from 100 women with confirmed SARS‐CoV‐2 infection during pregnancy and has since expanded nationally (https://www.psanz.com.au/covid-19/). The third priority was to address the exclusion of pregnant women from COVID‐19 treatment trials, which occurred despite the fact that many of the investigational drugs had established pregnancy safety profiles.4 The Australasian COVID‐19 Trial (ASCOT) is an international multicentre randomised adaptive platform clinical trial of COVID‐19 therapies (https://www.ascot‐trial.edu.au). After representations from the maternity sector, a pregnancy ASCOT working group tasked with facilitating the safe inclusion of pregnant women was appointed, which established a welcome precedent for inclusion of pregnant women in future clinical research.5 The CoMaND and CHOPAN collaborations are exemplars of clinician‐led initiatives for data‐informed emergency responses in maternity care. It is anticipated that these resources will be of ongoing value into the COVID‐19 vaccination era. Successful advocacy for the inclusion of pregnant women in clinical trials may be another positive legacy of the COVID‐19 pandemic. Their safe inclusion in clinical trials takes us a step closer to an equitable health service, ensuring we generate a robust evidence base to direct clinical care for pregnant women and their children. Box – An example of outcome reporting from the fifth CoMaND report2 Denominator: number of singleton babies at ≥ 20 weeks’ gestation. Numerator: number of babies who meet the denominator criteria with birth weight ≥ 90th percentile adjusted for fetal sex and gestational age. Pre‐pandemic median: 8.75%. Significant shifts (≥ 6 weeks above the pre‐pandemic median) indicated with red arrows. Percentile source: Dobbins et al.3

Lisa Hui · Clare Whitehead · Susan P Walker

Acknowledging the loss can go a long way towards healing the complex grief related to ectopic pregnancies

Sarah Saunders