Letters

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Alexander Larcombe · Sebastien Allard · Benjamin Mullins

In reply

Alexander Larcombe · Sebastien Allard · Benjamin Mullins

In reply

Betty SH Chan · Vicky Sheppeard · Andrew H Dawson

To the Editor: Iorfino and colleagues1 reported that “two in three young people with emerging mental disorders did not experience meaningful improvement in social and occupational functioning during two years of early intervention care”. Their sample was drawn from two headspace sites. This sounds alarming, especially considering that the study is exemplary in its longitudinal design, large sample size, and robust statistical analyses. Nevertheless, clinicians should be mindful of making too much of these results. The primary weakness of this study is the measure used: the Social and Occupational Functioning Assessment Scale (SOFAS). A systematic review of measures of functioning considered evaluating the SOFAS, yet excluded it based on the grounds that “the SOFAS has been superseded by the Personal and Social Performance Scale (PSP), which demonstrates stronger psychometric performance”.2 A study in 2007 stated that “the PSP scale is proposed as an improvement over the [Global Assessment of Functioning] and SOFAS because of its clear operational instructions on how to rate the severity of disability and its distinction between levels of impairment”.3 A similar issue was noted in 2000.4 Suffice to say, the SOFAS is a superseded measure of social and occupational functioning. This is apparent at the theoretical level. The SOFAS is a single item measure, rated on a scale of 0–100, for both social and occupational functioning. How is a clinician meant to score this measure when a young person presents functioning highly in their schooling, yet poorly in their social life? Or when things are going well with friends, yet poorly with their family? With this in mind, it is no surprise that three out of the four trajectories for young people’s mental health journeys identified by Iorfino and colleagues1 demonstrated no significant improvement. This is indicative of a broader issue identified in a systematic review of 189 articles, which reported that only nine mental health outcome measures in the published literature examined functional outcomes. Of these, “no measures were designed specifically for young people aged 12 to 25 years”.5 In short, the SOFAS is an out‐of‐date, adult measure with poor inter‐rater reliability. The study by Iorfino et al1 is what we need, but not what we are ready for. There is an urgent need in youth mental health services to have valid, reliable measures of social and occupational functioning that have good construct validity. There is an urgent research need for the development of such measures that have robust psychometric properties and clinical utility. Until this issue is resolved, attempting to predict pathways of care, or measure the efficacy of these services at a population level, will remain a guessing game. Future studies should focus on the development and evaluation of these measures. The collateral damage if researchers continue to use these measures will be the young people in need of early intervention.

Peter J Lenehan

In reply

Frank Iorfino · Elizabeth M Scott · Ian B Hickie

To the Editor: We write regarding the study by Wilmott and colleagues1 and the accompanying editorial by McLaren and Mewett.2 There are data of interest in the study that are not found in the limited Victorian voluntary assisted dying (VAD) review reports. Notable is that four doctor participants had assessed more than 25 people each in the first year of VAD in Victoria. Given that 124 people died by VAD in the first year, the high caseload of a handful of participants highlights that few doctors choose to be VAD assessors. With a large proportion of assessments being carried out by only a strongly supportive few, this raises potential concerns about the independence of assessments, when the doctors who are the gatekeepers of VAD work together in small groups to determine eligibility. There is an association between clinicians willing to provide a hastened death (where this is legal) and advanced cancer patients in palliative care wanting just that.3 Some participants in the study acknowledged that VAD consultations via telehealth are a “second rate solution”.1 However, the legislative push for VAD telehealth assessments continues with an amendment currently before the Victorian parliament, even though this puts access ahead of safety, making it harder to exclude depression or coercion.4 It was useful to be reminded that Victorian guidelines prohibit the use of telehealth for VAD consultations due to federal criminal laws that ban suicide discussions on carriage services. However, it is known that some Victorian VAD consultations have already been conducted via telehealth.5 The editorialists state that evidence is needed to guide VAD practice that to date has been based on opinion and personal viewpoint.2 The evidence base to support the need for VAD should have been identified before and not after legalisation. Stories of distressing deaths reported by relatives can be misleading, especially when these conflict with published palliative care research that suggests excellent symptom control in dying Australians who can access and who accept specialist palliative care.6 While VAD as a new practice receives much attention, its availability does nothing to help the many thousands of Victorians each year who do not want assisted suicide but who struggle with unmet palliative care needs. Despite the time and money spent on VAD access, the palliative care needs of most Victorians at the end of life still remain largely unmet.7 Other Australian states and territories should be aware of this.

Marion T Harris · Maria C Cigolini

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Lindy Willmott · Ben P White · Marcus Sellars

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Cameron J McLaren · Greg Mewett

To the Editor: Close and colleagues raise some important issues in their article on voluntary assisted dying (VAD) and telehealth.1 For the most part, their four key considerations give good practical advice to clinicians trying to work around Commonwealth laws introduced for a substantially unrelated purpose. A scenario they do not address is where a patient has been assessed as eligible for VAD, and then needs to discuss with the doctor by telehealth the choice between having lethal medication administered to them, or taking it themself (self‐administration). This is already an issue in Western Australia, and will become an issue in Tasmania and Queensland; not so much in Victoria or South Australia, where this choice is essentially restricted by clinical criteria set out in the legislation. In the above scenario, it needs to be made clear to the patient that the doctor is not favouring self‐administration over practitioner administration, but has an open mind in talking through this choice by telehealth with the patient. Close and colleagues are right to caution against using telehealth to discuss the VAD medication protocol for self‐administration, but their advice to have such discussions in person is not particularly helpful when the doctor is remote from the patient. When self‐administration is chosen, Western Australian law requires written instructions to be provided to the patient by the doctor and the applicable pharmacist on how to prepare and take the lethal medication.2 It can be explained that these instructions will be provided as hard copy, with the doctor making clear that nothing said to the patient over telehealth should be construed as instruction on how to prepare or take the medication. When the pharmacist delivers the medication to the patient for self‐administration, as is the practice in Victoria and Western Australia, any question about the written instructions can be dealt with face to face, as part of the counselling of patients expected of pharmacists under guidelines issued by the Pharmacy Board of Australia.3

Richard SW Lugg

To the Editor: Kaur and colleagues propose the ABCD (abbreviated, brief, comprehensive, detailed) approach for older patients.1 Further to that, we propose extending the mnemonic to ABCDEF with E for efficiency and F for feasibility. This would make it more realistic. The Australian population is ageing. Older patients are often beset by numerous comorbidities. Innovative approaches to facilitate minimisation of hospitalisation and early discharge of frail older patients are urgently needed. Comprehensive geriatric assessment is advocated as the gold standard of managing older patients’ medical needs to improve quality of life. It requires specialist geriatrician assessment in geriatric evaluation and management wards. Unfortunately, a minority of older patients end up being admitted to geriatric evaluation and management units, whereas acute medical beds are mostly occupied by older patients where access to comprehensive geriatric assessment is poor.2 Further, the cost‐effectiveness of comprehensive geriatric assessment in specialised units remains unknown and its utility in reducing length of stay and avoiding readmissions is limited.3 The ABCD concept is intriguing. However, it is unlikely to resolve the dilemma of bed occupancy and length of stay of older patients unless the approach is sufficiently efficient and feasible. These elements conveniently extend the mnemonic to ABCDEF. By “efficiency” we mean efficiency in early recognition of their acute issues, establishing a multimodal approach of therapeutic interventions and discharge planning. “Feasibility” of utilising ABCD in various hospital settings must also be considered. Hospital in the home in appropriately selected patients is an example of efficient and feasible comprehensive geriatric assessment based on the ABCD approach.4 For the ABCD to be properly executed, E (efficiency) and F (feasibility) are integral to this approach. Timely access to specialist geriatric care along with improved delivery of primary care for older people are key issues that need to be concurrently addressed.5

Alaa Alghamry · Joseph C Lee

In reply

Paven Kaur

To the Editor: In August 2020, the South Eastern Sydney Public Health Unit, located in New South Wales, Australia, received a statutory laboratory notification of an elevated blood lead level of 0.34 µmol/L in a preschool‐aged child recently diagnosed with autism. This was above the 0.24 µmol/L level requiring notification under the Public Health Act 2010 (NSW). The test had been requested by the child's paediatrician due to concern about the child’s recent consumption of an oral Ayurvedic medicine prescribed by a naturopath. Our environmental health officers undertook a home lead assessment, during which a soil sample and the Ayurvedic medication sample were taken for heavy metals analysis. The soil lead concentration was 160 mg/kg. The medication was labelled Manasmithra Vatika (MV), manufactured in India (Box). Analysis revealed that it comprised 0.96% lead by weight. The naturopath indicated that they had prescribed the medication to other child and adult patients, some of whom were seeking treatment for autism. Most consultations were conducted online and the prescriptions were purchased online. We were concerned about the risk of lead toxicity in the naturopath’s other patients who had been prescribed MV, and mounted a public health investigation in order to inform patients of their risk, to advise them to cease use of the medication, and to identify the extent of the problem. The naturopath provided a list of 28 patients (13 children) to whom they had prescribed the medication. We directly followed up the 12 NSW patients (other than the index case), asking whether they had taken MV, and, if so, in what dosage and over what period. We advised those who were taking MV to immediately cease its use, and to seek blood lead level testing through their own doctors. We asked patients to provide us with any remaining MV for lead analysis. Five patients provided MV samples; analysis showed lead content of 0.74–0.96% (mean, 0.81%) by weight. Four patients had an elevated blood lead level ranging from 0.30 to 0.68 µmol/L (reference interval, < 0.24 µmol/L). A fifth patient, whose blood lead level was undetectable (< 0.1 µmol/L) had ceased taking the MV at least 3 months before measurement. Based on these findings, we initiated a multi‐agency investigation involving NSW and Australian government regulatory bodies. Action taken against the naturopath by the Australian Health Practitioner Regulation Agency and NSW Health Care Complaints Commission prohibited them from treating medical conditions, such as autism. The naturopath voluntarily ceased prescribing MV and immediately contacted their patients to inform them of the lead adulteration of the preparation. The NSW distributor of the MV medication was investigated by the NSW Health Pharmaceutical Regulatory Unit and the Therapeutic Goods Administration, leading to the distributor ceasing to import the adulterated MV. The Therapeutic Goods Administration issued a public warning regarding the presence of lead in MV preparations generally, without naming an implicated brand or source.1 Lead exposure in children can be linked to reduced intelligence, and behavioural and developmental impacts.2,3 Ayurvedic medicines are formulated and prescribed based on ancient Indian texts. Although they are herbally based, Ayurevedic texts also provide for formulation with heavy metals including lead.4 Their use has been associated with elevated blood lead levels in patients.5 The public health investigation and subsequent multi‐agency intervention we have described prevented ongoing exposure of patients to a lead‐contaminated herbal product. As a result of this investigation, we suggest: ▪ health practitioner awareness be raised regarding the risks of recommending or prescribing unregistered, imported medications; ▪ clinicians consider testing for blood lead in patients who have consumed unregistered, imported Ayurvedic medications; ▪ public health professionals be engaged in the investigation of patients with elevated blood lead levels in the absence of an occupational source; ▪ community awareness be raised regarding the risk of consuming unregistered, imported Ayurvedic medications; and ▪ a multi‐agency response is required to effectively address prescribing of unsafe complementary medications by unregistered health professionals. Box – Manismithra Vatika tablets provided by a patient with an elevated blood lead level

Mark J Ferson · Sinead Flanigan · Toni Cains

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

To the Editor: We congratulate Wright and Versteeg1 for their timely article outlining Australian and international experience of patient enrolment in general practice. Missing from the debate, however, is any reflection on the Practice Incentives Program – Indigenous Health Incentive (PIP‐IHI), a voluntary general practice enrolment of Indigenous patients intended to improve chronic illness care. Here, to offer transferrable lessons for informing the rollout of the Voluntary Patient Enrolment scheme (called MyGP),2 we draw on findings from the Sentinel Sites Evaluation — based on administrative data from the Department of Health and more than 700 interviews with Aboriginal health services and general practice3 — and submissions made to the PIP‐IHI review by key stakeholders in 2019.4,5 First, the lack of existing clinical information system capacity to record if a patient was registered with the PIP‐IHI hindered its implementation. Of particular concern were the separate spreadsheets developed to manage patient registration. Short term gains from developing parallel systems did not advance systematic development and use of follow‐up and recall systems in the longer term. Thus, investment in patient registration systems that advance clinical information systems is required. Second, a perception that the PIP‐IHI rewarded paperwork but did not improve clinical outcomes was a disincentive for participation. Administrative requirements were widely considered too burdensome, particularly, annual patient registration that required practices to determine whether patients were previously registered or had duplicate registrations. This resulted in low patient re‐registrations, limiting the potential for the measure to provide longer term community benefit. Hence, to improve participation, the administration burden must be minimised, with flexible, simplified one‐off registration procedures that enable patients to change general practices. Last, given that patients registered for the PIP‐IHI were expected to have a diagnosed chronic disease, it is notable that Tier 1 or Tier 2 payments reflecting continuity of care and planned review were not triggered for about 30% of patients.6 A substantial proportion of PIP‐IHI‐registered patients were either not regularly attending general practices or the practices were not billing for care in a way that triggered payments. Practice staff attributed this to inadequacies in their recall and reminder systems and to difficulties in contacting patients for recall and in getting them to attend a follow‐up appointment. Therefore, incentives need to encourage better care, not just enrolments.

Jodie Bailie · Alison Laycock · Ross S Bailie

In reply

Michael Wright · Roald Versteeg

To the Editor: We congratulate Backholer and colleagues for their article.1 This is a timely, powerful call to action. One in six Australians live with a hearing condition, a proportion that is set to rise as our population ages. However, prevalence also increases with longer exposure to loud noise and is higher in Indigenous and lower socio‐economic status populations. As audiologists, researchers and consumer advocates, we believe that taking a social determinants approach is the best way to significantly improve health and wellbeing. Historically, approaches to hearing health in Australia have been device‐centric.2 With the Roadmap for Hearing Health,3 collaboratively created by the sector and the federal government, there is an opportunity to change direction. To date, with the notable exception of initiatives in Aboriginal communities,4 hearing health has not been approached through the lens of the social determinants of health. We are currently working to change this. Physical and digital spaces determine the experience of hearing conditions5 to such an extent that interventions for accessibility can have as much impact on wellbeing as health interventions. Across all specialties, we encourage clinicians and researchers to forge connections with the disciplines of architecture, town planning, acoustic engineering, communications, and technology, to name a few. The HearMe report,5 which combines lived experience narratives with expertise from far beyond the health sector, was a first step in this direction. The work of the Obesity Collective is to be commended for taking a similar approach to an urgent public health issue (www.obesityaustralia.org). We live in a hearing society, making a person’s hearing status itself a determinant of health. People living with hearing conditions face stigma, discrimination and access barriers, including to health care. As highlighted by Backholer and colleagues,1 the coronavirus disease 2019 (COVID‐19) pandemic was a great disruptor and accelerator, showing us that rapid, society‐wide transformation is achievable. A world that is fulfilling, accessible, inclusive and respectful for people living with hearing conditions is possible if we centre the diversity of lived experience and commit to action on the social determinants of hearing health across the life course.

Jessica Vitkovic · Caitlin Barr · Bamini Gopinath

To the Editor: With great interest we read the article by Weise and colleagues,1 which presents the results of a retrospective cohort study that found higher age‐standardised rates of potentially preventable hospitalisation in people with intellectual disability in New South Wales compared with the general NSW population. Given the great health inequality of people with intellectual disability, we acknowledge the authors’ effort to conduct this valuable study. However, after reading the article, we were left with two questions. First, to be able to interpret the results of this study, a clear description of the population characteristics of both groups is indispensable. Information about parameters such as age and sex of both populations and about the design of the database is of crucial importance. The absence of this information makes it difficult to get a good picture of the population studied and any limitations or biases that need to be taken into account. We recognise that this type of data is not always easy to collect, especially when working with large population databases. Given its importance for interpretation purposes, we see this as a crucial point of attention for future research. Second, in this study, potentially preventable hospitalisations were identified using the definition in the National Healthcare Agreement, progress indicator 18.2 However, in addition to this definition, the circumstances and the exact reason for hospital admission have not been explored, which makes it difficult to conclude whether all hospital admissions could actually have been prevented in clinical practice. Further research would therefore be of great added value to unravel the significance of the study findings by exploring the differences in the rates of potentially preventable hospitalisations to guide possible future reforms of primary and community health care. In conclusion, the article provided us with important knowledge about the rates of potentially preventable hospitalisation of people with intellectual disability. However, the questions mentioned above need to be answered and further research should be conducted to allow a good interpretation of the results.

Karel L Wel · Lydia Kleinjan · Marleen J Leeuw

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Janelle C Weise · Preeyaporn Srasuebkul · Julian N Trollor