Volume 214 Issue 8

One in three COVID‐19 patients diagnosed with mental health conditions One in three COVID‐19 survivors received a neurological or psychiatric diagnosis within 6 months of infection with severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), an observational study published in The Lancet Psychiatry estimates. The study looked at 14 neurological and mental health disorders. The researchers analysed data from the electronic health records of 236 379 patients with COVID‐19 from the US‐based TriNetX network, which includes more than 81 million people. Patients older than 10 years who became infected with SARS‐CoV‐2 after 20 January 2020, and were still alive on 13 December 2020, were included in the analysis. This group was compared with 105 579 patients diagnosed with influenza and 236 038 patients diagnosed with any respiratory tract infection (including influenza). Overall, the estimated incidence of being diagnosed with a neurological or mental health disorder following COVID‐19 infection was 34%. For 13% of these people, it was their first recorded neurological or psychiatric diagnosis. The most common diagnoses after COVID‐19 were anxiety disorders (17% of patients), mood disorders (14%), substance misuse disorders (7%), and insomnia (5%). The incidence of neurological outcomes was lower, including 0.6% for brain haemorrhage, 2.1% for ischaemic stroke, and 0.7% for dementia. Risks of a neurological or psychiatric diagnosis were greatest in, but not limited to, patients with severe COVID‐19. Compared with the overall 34% incidence, a neurological or psychiatric diagnosis occurred in 38% of those who had been admitted to hospital, 46% of those in intensive care, and 62% in those who had delirium (encephalopathy) during their COVID‐19 infection. The authors noted several limitations to their study. First, the completeness and accuracy of the electronic health records was not known. Second, many people with COVID‐19 have mild or no symptoms and do not present for health care; the people studied here are therefore likely to have been more severely affected than the general population. Third, the severity and course of the neurological and psychiatric disorders was not known. https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(21)00084-5/fulltext E‐cigarettes may help smokers quit for good E‐cigarettes may be more effective in helping smokers quit than nicotine replacement therapies such as patches and gum, according to University of Queensland research published in Addictive Behaviours. The study looked at 16 different smoking and vaping trials, with a total of 12 754 participants. It assessed e‐cigarettes and approved nicotine replacement therapies including nicotine patches, gum, lozenges, mouth spray, inhalators and intranasal sprays. “Our study found e‐cigarettes are 50% more effective than nicotine replacement therapy, and more than 100% more effective than the placebo,” said lead author Dr Gary Chan, from UQ’s National Centre for Youth Substance Use Research. “Electronic cigarettes containing nicotine may be more effective than nicotine replacement products because they deliver a small amount of nicotine to alleviate withdrawal symptoms and provide a similar behavioural and sensory experience as smoking tobacco products. We hope the findings from this study can be used to better inform policies around e‐cigarettes and cigarette smoking.” https://www.sciencedirect.com/science/article/abs/pii/S0306460321000976

Implementing voluntary assisted dying legislation demands respectful communication and collaboration between health professionals and community The Voluntary Assisted Dying Act 2017 (Vic) (VAD Act) was passed by the Victorian Parliament in November 2017 and came into effect on 19 June 2019.1 The VAD Act is the only legislation of its kind implemented in Australia, but there are several other international jurisdictions where comparable legislations apply.2,3,4 Victoria is the first state in Australia to implement voluntary assisted dying (VAD). There is a dearth of local evidence available which explores the implementation of assisted dying services into a hospital setting, although potential ethical challenges have been identified.2,5,6 This article aims to outline the experience of a tertiary public health service in Melbourne’s western suburbs which implemented VAD in 2019 and the resultant policies and procedures. With the enactment of the VAD Act, Victorian public health services were expected to develop policies and procedures which apply when a patient requests VAD or related information.7 As a tertiary public health service in Victoria, the health service used policies and guidelines suggested by the Department of Health and Human Services (DHHS) and shared documents from other metropolitan tertiary hospitals as a basis for developing local policies and procedures.7,8 The Victorian legislation provided the eligibility criteria and necessary steps required to access VAD, including timing of requests, medical assessments, medication prescription, reporting and professional requirements.1 In mid‐2018, the health service established a VAD Working Group with senior professional and executive representation, including the Chief Medical Officer; the General Counsel; the Executive Director, Nursing and Midwifery; relevant medical heads of units, senior nurses, allied health representatives, and the Senior Clinical Communications Advisor. The Clinical Communications Advisor conducted 1:1 consultations with the 25 Working Group members to explore the impact of VAD legislation on their professional group and clinical practice between September and December 2018. The outcomes of these consultations highlighted the systemic and ethical complexities inherent in implementing VAD and informed the next steps, including the need to engage with a range of appropriately skilled and experienced clinicians throughout the implementation phase.4 A key consideration during the implementation phase was balancing staff members’ right to conscientiously object to supporting patients when the assistance was related to VAD, with the expectation that health professionals would continue to provide care unrelated to VAD.5 Capacity for moral injury for staff for whom their beliefs and values were at odds with the employing organisation’s approach to VAD needed to be recognised and addressed throughout the implementation process.5,9 To assist with planning, the health service had to decide which VAD model of care pathway would be provided — either A, B or C10 (Supporting Information, appendix 1). The pathway selected by the health service was dependent on the number of suitably qualified medical professionals willing to perform VAD coordination and/or consultation roles, in line with VAD legislation requirements. In 2019, the hospital’s medical professionals were invited to complete an anonymous survey asking them to indicate their willingness to participate in VAD. This survey achieved 208 responses (a 17% response rate), 106 of those were from senior medical staff, with 72% of respondents supporting a patient’s access to VAD at the health service. In addition, eight senior medical staff members expressed a willingness to be involved in the facilitation of VAD. The survey results guided the health service’s management to determine Pathway A as the appropriate model of care for this health service. In parallel with this survey, training for VAD was provided by the DHHS‐led VAD Implementation Taskforce. During these sessions, the need for local VAD procedures were identified, as staff members required further guidance to navigate patients’ requests for VAD and to ensure the health service adhered to legislative requirements. Importantly, the procedures needed to support the right of staff to conscientiously object to VAD while fulfilling lawful access to care.5 The multidisciplinary Working Group met 12 times over an 8‐month period, with the first meeting occurring in November 2018. As implementation drew closer, the Working Group focused on a number of actions to operationalise the legislation, including the development of two VAD procedural flow charts for requesting and assessing VAD (Box 1) and for VAD medication and administration (Box 2). These procedural flow charts, as well as the organisation‐wide VAD policy and procedures and the DHHS guidelines, were distributed to all staff electronically and made available on the organisation’s intranet. The procedures developed applied to all staff, including agency and contract staff. Two open‐forums (“grand rounds”) were held to educate staff on VAD legislation, inform staff of the Pathway A model of care, and launch the hospital’s VAD policy and procedures (Supporting Information, appendices 2 and 3). All clinical staff were invited to attend. These forums attracted more than 500 participants and were part didactic and part panel‐led, with interactive audience discussion. Over 50 questions were received through the anonymous electronic tool Mentimeter (www.mentimeter.com) and verbal contributions were documented. A broad range of perspectives, concerns and clinical scenarios posed throughout these sessions prompted the development of a comprehensive frequently asked questions document, which provided further guidance regarding the integration of VAD into clinical practice. Despite the VAD Act coming into effect from June 2019, the health service wanted to provide adequate VAD advice and training before it became an option for patients. The health service thus determined that the VAD policy, procedures and flow charts would be enacted in July 2019. Challenges implementing voluntary assisted dying There were a number of challenges during the planning phase. Primarily, the health service needing to balance the guiding principles of the legislation, which focused on patient‐centred decisions, while embedding practices to mitigate organisational risk. One example surfaced when the Working Group were deciding where VAD medication would be stored during an inpatient stay. The patient’s autonomy was core, but other safety issues were factored in. In this instance, the decision was made to store the patient’s VAD medication box securely within the central pharmacy rather than on the ward or at the patient’s bedside. Perhaps the largest challenge was fulfilling the responsibility of a Pathway A public health service to provide VAD as an option while respecting the staff member’s decision to conscientiously object to facilitating or being involved in VAD. The need to consider each case individually was highlighted, as it was recognised that there is a spectrum of views in relation to conscientiously objecting. Broad consultation enabled a sensitive and considerate implementation plan, including the addition of known conscientious objectors in the Working Group. Processes were embedded to allow conscientious objectors to distance themselves when patients request VAD, including the provision of informed agency nursing staff to replace potential conscientious objectors on a shift, and the broad promotion of a single contact phone number, to which conscientious objectors could anonymously call and hand over this responsibility. Without comparable local evidence, the expected demand for VAD was inferred from international evidence, which predicted that a low number of people would request VAD.2,3 Over a 14‐month period (June 2019 to September 2020), the health service received 42 patient requests for VAD, with four patients progressing to a prescription of VAD medications and dying as a result. Three of these four patients died after receiving VAD as inpatients and one died at home after being discharged from the health service. Patients who requested VAD were cared for across a number of services and received concurrent palliative care as part of appropriate end‐of‐life care management. The patients who died after receiving VAD were cared for in the ward that was most familiar and suited to their needs; palliative care was provided by the treating team, with specialist input as required. Most VAD requests were from patients in the final weeks of their lives, who therefore did not survive the full length of the VAD assessment process. This observation made it imperative that VAD processes complemented end‐of‐life care, thus not denying the patient and their loved ones appropriate palliative and bereavement care respectively. Indeed, a core tenet of staff education was that progression of VAD may occur during end‐of‐life care; therefore, palliative and comfort care must continue concurrently with VAD processes. Implementing VAD in a hospital setting demanded sensitive, honest and respectful communication between multiple health professional groups and the community, particularly between individuals with opposing views. A significant amount of time was spent engaging with and listening to staff with a myriad of perspectives. The framework provided by the VAD legislation and the DHHS VAD Implementation Taskforce enabled the health service to develop local policy, procedures and resources that most appropriately serve the community. The multidisciplinary Working Group proved a useful forum to deal with the complex issues inherent in implementing a progressive legislation into a large health service. Since the implementation of VAD, statewide monitoring and surveillance of VAD has occurred through multisite data collection and mandated reporting. Locally, discussion of case studies, engagement in multisite research and staff consultation will continue to provide vital guidance to the health service when delivering VAD, improving its processes and responding to the needs of patients and staff. Box 1 – Voluntary assisted dying request and assessment procedural flow chart Source: Western Health. Figure reproduced with permission. Box 2 – Voluntary assisted dying medication and administration procedural flow chart EMR = electronic medical record; iPM = patient administration system. Source: Western Health. Figure reproduced with permission.

Sarah Booth · Paul Eleftheriou · Claire Moody

International use of acute kidney injury care bundles, including e-alerts, represents a potential pathway for significant improvement in acute kidney injury management in Australia

Anna C Bendall · Sven‐Jean Tan · Emily J See · Nigel D Toussaint

In a new MS diagnosis, immunisation status may be overlooked — careful planning from early in the treatment course is key Multiple sclerosis (MS) is an autoimmune disorder treated with immunomodulatory or immunosuppressive disease‐modifying therapies (DMTs). Immunosuppression predisposes to infection risk, including opportunistic infections; a higher long term risk of some infection‐related malignancies is also likely. Infections in patients with MS may result in increased relapses, functional decline and pregnancy complications.1 Immunisations play a critical role in preventing viral and bacterial infections, and in the setting of DMTs, they require careful and individualised planning from early in the treatment course. Here we provide an Australian perspective on vaccine safety and efficacy when given with DMTs. General vaccination considerations in patients with MS The immunisation status of patients should be considered at the time of MS diagnosis. Standard investigations before DMT initiation are highlighted in Box 1. A full course of vaccinations should be considered for non‐immune patients before commencing a DMT; this is sometimes forgotten in the urgency of managing a new MS diagnosis. Inactivated (non‐live) vaccines contain a killed/inactivated or subunit/conjugate of the pathogen and can be safely administered with DMTs. The immunogenicity of these vaccines when used with DMTs has not been conclusively established. Live vaccinations use an attenuated viral or bacterial strain and are contraindicated with most DMTs because of the risk of disseminated infection when used in immunocompromised states.3 Administration of live vaccines is recommended before DMT commencement (Box 2). Routine vaccinations are not associated with increased MS relapse risk,10 although the risk of relapse associated with yellow fever vaccination remains unclear.11 Immunisations administered in accordance with local guidelines are considered the best strategy for minimising the risk of infections that could trigger MS relapses.9,12 In patients experiencing clinically significant relapses, delaying vaccine administration has been suggested until patients have stabilised and show signs of improvement (typically 4–6 weeks).12 Additional consideration is required for women with MS who are planning a pregnancy. Women should receive live vaccinations before conception to prevent adverse pregnancy outcomes;13 however, DMT cessation to allow vaccination before conception is often not feasible. Vaccination should therefore be explored as early as possible, preferably before commencement of DMT, as it may represent a one‐off opportunity. It is generally considered safe to vaccinate close immunocompetent contacts (eg, family members) of patients on DMTs without risk of disseminated infection.14 Due to the potential for disseminated infection, we recommend delaying recommencement of a DMT by at least 4–6 weeks following the final dose of a live vaccine. Should a patient on a DMT require live vaccines, treatment cessation should be followed by an appropriate washout period before immunisation. No evidence‐based guidelines exist for washout periods between DMTs.15 Patients receiving DMTs with long lasting biological effects (eg, ocrelizumab, alemtuzumab, cladribine) may require prolonged treatment interruption and monitoring to ensure a return to immunocompetency before vaccination (Box 3). The risk of delayed DMT recommencement, including risk of relapse and worsening neurological disability, should be carefully considered against the benefits of immunisation. Ultimately, the long term benefits of vaccination may outweigh the short term risk of relapses. Confirming seroconversion after vaccination is sometimes advised to ensure those who do not generate adequate titres are informed about any possible risk associated with future exposure. An attenuated humoral response is seen with ocrelizumab therapy.27 However, it should be noted that serological testing is insensitive to the contribution of vaccine‐associated cellular immunity, which is likely to offer at least partial protection.29 Individual vaccinations and specific considerations Influenza (non‐live) The seasonal influenza vaccine is considered safe for patients with MS regardless of DMT exposure and is recommended annually.4 Efficacy may be reduced by some DMTs, and seroconversion is attenuated by anti‐CD20 therapy.27 Primary varicella (live) The risks associated with varicella zoster virus infection in patients with MS receiving DMTs highlight the importance of vaccination in this population.30 Vaccination should be considered before DMT commencement in patients lacking demonstrable serological immunity who have an absent or unclear history of chickenpox, shingles or vaccination.31 Varicella zoster reactivation (live) Zostavax (Merck) reduces the risk of shingles and post herpetic neuralgia; it is a larger dose of the live attenuated primary varicella vaccine and is therefore also contraindicated with DMTs.5 Vaccination should be considered 4–6 weeks before commencing any DMT; however, reimbursement in many countries is reserved for older age groups, in whom efficacy may be uncertain.7 Measles–mumps–rubella (live) The combined measles–mumps–rubella vaccine is part of childhood vaccination schemes in most high income countries. It should be administered to patients who lack immunity to any of these viruses before commencing DMT.5 Women planning future pregnancy are advised to have immunity against rubella to prevent adverse outcomes such as miscarriage and congenital defects.5 Pneumococcus (non‐live) Australian guidelines for pneumococcal vaccination are currently in flux; readers are encouraged to check the Australian immunisation handbook for up‐to‐date recommendations.5 Two non‐live vaccines against Streptococcus pneumoniae are available in Australia: a 13‐valent conjugate and a 23‐valent polysaccharide vaccine. The benefits of pneumococcal immunity are potentially significant in the MS population, and the multidose schedule should be particularly applied to patients receiving B cell‐depleting agents, or after immune‐ablative therapies.5 Hepatitis B virus (non‐live) Patients receiving DMTs enter a higher risk category for hepatitis B given their chronic condition, immunocompromise and potentially frequent health care contact.5 Other risk factors to consider include frequent close contact with blood, compromised immunity, intercourse or residence with someone infected with hepatitis B virus, having more than one sexual partner, and frequent travel. To optimise the immune response, the first of three doses should be given before DMT exposure where possible. To prevent treatment delays the remaining doses may be given after DMT commencement. Specialist referral before DMT commencement is required for patients with serological evidence of prior (core antibody positive and surface antigen negative) or chronic (surface antigen positive and/or DNA positive) hepatitis B virus infection, for surveillance and antiviral therapy to mitigate reactivation risk. This is a particular risk with fingolimod and lymphocyte‐ablative therapies. Diphtheria–tetanus–pertussis (non‐live) Vaccination against the highly infectious Bordetella pertussis is routine in Australian children, with a booster recommended for special risk adults including those in close contact with health care, children and infants.5 Vaccination with the diphtheria–tetanus–pertussis vaccine should be strongly considered for patients with MS who lack immunity or have not have a booster within the previous 5 years. Meningococcal disease (non‐live) Combination quadrivalent conjugate meningococcal vaccination is routine for Australian infants, children and adolescents.5 Given their chronic medical condition and immunosuppression, patients with MS treated with DMTs are recommended to receive both combination quadrivalent conjugate and non‐routine meningococcal B vaccinations.5 Further risk factors include frequent travel, individuals living in close quarters, and smoking. Yellow fever (live) Patients with MS planning travel to yellow fever endemic regions should be encouraged to think carefully about their itinerary. A small study of patients not on highly effective DMTs observed a significant increase in relapse rate following exposure to the yellow fever vaccine,11 although this was not corroborated in a recent case series.32 When yellow fever vaccination is essential, DMT cessation with a washout period is required. Given a single‐dose vaccine is protective for life, yellow fever vaccination could be offered before DMT commencement, especially if DMT initiation is delayed for other vaccinations. Concerns regarding the elevated risk of vaccine‐related adverse events in older patients should also be considered.33 When the risk of vaccination outweighs the benefits and the itinerary cannot be changed, a letter detailing why the vaccine cannot be administered should be provided. Patients should also be informed of the quarantine requirements and national policies of their destination. Human papillomavirus (non‐live) Substantial evidence suggests immunocompromise predisposes to persistent human papillomavirus (HPV) infection and related diseases, including cervical and anal cancer.34 HPV vaccination is not routinely recommended for adults, except for immunocompromised patients, and men who have sex with men.35,36 Although data on women with MS are lacking, the nonavalent HPV vaccine should be considered in non‐vaccinated adults and adolescents preparing for, or already taking, DMTs. The use of cervical HPV DNA testing to determine potential benefit from vaccination is not recommended.35,36 The Australian National Cervical Screening Program recommends immunocompromised women with a negative HPV result be re‐screened every 3 years (rather than every 5 years in immunocompetent women).35,36 Travel vaccines Patients with MS should be counselled regarding their itinerary, need to travel, and risks of infections in the context of their travel plans and prescribed DMT. As with other vaccines, non‐live vaccinations are considered safe, whereas live vaccines are contraindicated in those receiving DMTs and must be given after an appropriate washout period. Patients should be made aware that the immunogenicity of non‐live vaccines in the context of DMTs is inadequately studied. Referral to a specialised travel medicine clinic is recommended. Summary Determining immunisation status when commencing DMTs is key, as is an individualised approach to risk–benefit assessment when considering vaccinations. Live vaccinations are contraindicated in patients once they have commenced a DMT. Although we consider it safe to combine non‐live vaccinations with DMTs, data are limited regarding their efficacy and durability. Box 1 – Standard safety and immune status workup before commencing disease‐modifying therapy Varicella zoster serology (IgG) Measles serology (IgG) Mumps serology (IgG) Rubella serology (IgG) Hepatitis B (surface antibody and antigen, and core antibody) and C serology Human immunodeficiency virus serology Syphilis serology Mycobacterium tuberculosis interferon‐γ release assay* and/or chest x‐ray Travel vaccine workup if clinically appropriate Additional considerations: vaccination and infection history; cervical screening * May be affected by immunosuppressive therapies taken at the time of testing; this has been established for patients on teriflunomide and may be the case for other drugs.2 Box 2 – Summary of vaccines Vaccine type Recommendations and comments Influenza* Safe and recommended annually for patients with MS, including those on DMTs4 Varicella zoster virus† primary infection (chickenpox) Give before DMT as two doses at least 1 month apart; consider reducing interval to 2 weeks if DMT commencement is urgent5 Avoid re‐checking varicella zoster virus serology after vaccination, as failure to seroconvert may not preclude functional immunity6 Delaying DMT commencement to retest for seroconversion is also not recommended When DMT cannot be delayed or ceased, antiviral prophylaxis could be considered in high risk circumstances until a window for vaccination arises Prophylaxis could be similarly considered if a patient is inadvertently given live vaccine while receiving DMT5 Varicella zoster virus† reactivation (shingles) Give before DMT Prophylaxis could be considered if a patient is inadvertently given live vaccine while receiving DMT5 Non‐live vaccine may prove useful to patients taking DMTs in future but is currently in global short supply7 Measles–mumps–rubella† Give before DMT in vaccine‐ and infection‐naïve patients — recommended as two doses, at least 1 month apart5 Recommended for women considering future pregnancy, if no evidence of immunity before DMT commencement Patients who lose serological immunity despite exposure or single‐dose vaccination may benefit from single‐dose revaccination8 Patients unable to receive vaccine require education about post‐exposure management Pneumococcus* Adults should be offered a single dose with a follow‐up dose after 5 years The multidose schedule should be particularly applied to patients receiving B cell‐depleting agents, or after immune‐ablative therapies. In adults without a history of pneumococcal vaccination, the preferred order is one dose of 13vPCV followed by a dose of 23vPPV 8 weeks later; if 23vPPV is administered first, then 13vPCV should be administered 1 year later5 Hepatitis B virus* Recommended for patients with MS, who generally fit at‐risk category owing to their chronic condition and immune status Three‐dose schedule at months 0, 1 and 6; where possible, first dose should be given before commencement of any DMT Some flexibility between dosing is permissible: minimal interval between doses 1 and 2 is 1 month; minimum of 2 months between doses 2 and 3; and 4 months between doses 1 and 35 Serological response should be measured and specialist advice sought for vaccine non‐responders Specialist referral before DMT commencement is required for patients with serological evidence of prior or chronic infection Diphtheria–tetanus–pertussis* Vaccination recommended for patients with MS lacking immunity; consider booster before DMT commencement Adults who sustain deep and/or dirty wounds and have not received the vaccine within the previous 5 years should be revaccinated with either diphtheria–tetanus–pertussis or diphtheria–tetanus vaccine5 Vaccination should not be delayed even in patients experiencing an active relapse, as the benefits are thought to outweigh the risks9 In addition, tetanus immunoglobulin is recommended for patients with defective humoral immunity (eg, anti‐CD20 therapy) who sustain such wounds Meningococcus* Patients with MS treated with DMTs are recommended to have both routine combination quadrivalent conjugate and non‐routine meningococcal B vaccinations Also recommended if close contact with laboratories, health care and young children has occurred Close contacts of meningococcal cases should also be considered for post‐exposure prophylaxis with vaccination5 Human papillomavirus* In Australia, vaccination at 12–13 years of age is routine for both females and males; those aged ≤ 19 years are eligible for a government‐funded vaccine, while older patients may need to self‐fund Three doses spaced at 0, 2, and 6 months for people > 15 years (two‐dose schedule for non‐immunocompromised aged under 14 years) Vaccination should be considered in DMT‐exposed, non‐vaccinated adults and adolescents Additional considerations for special groups Travel vaccines: yellow fever†, hepatitis A virus*, typhoid (oral† and intramuscular* vaccines), Japanese encephalitis†, rabies*, cholera†, polio (oral† and intramuscular* vaccines), tuberculosis (bacille Calmette–Guérin vaccine)†, dengue* (not yet available) Q fever* vaccine for people working in abattoirs 13vPCV = 13‐valent pneumococcal conjugate vaccine; 23vPPV = 23‐valent pneumococcal polysaccharide vaccine; DMT = disease‐modifying therapy; MS = multiple sclerosis. * Non‐live vaccine: safe with DMTs but immunogenicity not conclusively established. † Live vaccine: contraindicated with DMTs. Box 3 – Vaccine safety and efficacy with disease‐modifying therapies Disease‐modifying therapy Recommendations Vaccine use in clinical trials Corticosteroids Generally used to accelerate recovery in the setting of a relapse (eg, 3–5 days). Guidelines suggest avoiding vaccinations during clinical multiple sclerosis relapses.9,12 Low dose corticosteroids (< 20 mg/day): safe to give vaccinations.5 Higher dose steroids > 20 mg/day used for < 14 days: give live vaccines 1 month before or any time after treatment;5 some experts recommend waiting 2 weeks after higher dose steroids before giving live vaccines.16 Higher dose steroids used for > 14 days: wait 1 month before live vaccine use. Non‐live vaccines are safe. Teriflunomide Clinical trials and post marketing data suggest non‐live vaccinations are safe and effective during treatment.17 Live vaccines should be avoided during therapy and be given after a washout period of at least 6 months due to prolonged effects on the immune system. Although accelerated washout can be achieved using cholestyramine or activated charcoal, there are no data regarding earlier use of live vaccinations following this. Seasonal influenza vaccine was found to be safe and efficacious.18 A double‐blind placebo‐controlled study evaluated immune responses to a neoantigen (rabies) and recall antigens in healthy subjects treated with teriflunomide. The treatment group achieved seroprotective levels against rabies, albeit at reduced levels compared with the placebo group. Recall antigens were not affected, suggesting no adverse effect on cellular memory response.17Teriflunomide impairs tuberculosis interferon‐γ release assay, which should be cautiously interpreted in this setting.2 Dimethyl fumarate Clinical trials and post marketing data suggest non‐live vaccinations are safe and effective during treatment.19 Use of live vaccinations is not recommended during treatment. If required, the final live vaccine dose should be given 4–6 weeks before the commencement or recommencement of treatment. An open label multicentre study evaluated immune response to tetanus, diphtheria, polyvalent pneumococcal vaccine, and meningococcal conjugate vaccines in patients receiving dimethyl fumarate or interferon. Serological evidence consistent with protection for all vaccines was comparable between the two groups, with no safety concerns raised.19 Fingolimod Clinical trials and post marketing surveillance data suggest that non‐live vaccinations are safe with fingolimod, albeit with impaired efficacy. The use of live vaccinations is not recommended during treatment. A washout period of 2–3 months is recommended to enable immune reconstitution. There are no data to support the use of lymphocyte counts as a marker of immune reconstitution for vaccine safety. The commencement or recommencement of fingolimod should be delayed until 4–6 weeks after the final vaccine dose. Fingolimod has also been associated with infection‐associated malignancies such as cervical cancer. Careful observance of screening programs is recommended. A blinded randomised placebo‐controlled study evaluated vaccination response in 138 fingolimod‐treated patients. The response rates for novel antigen influenza vaccine (fingolimod v placebo) were 54% and 85%, respectively, at 3 weeks, and 43% and 75%, respectively, at 6 weeks after vaccination. For tetanus toxoid, response rates were 40% and 61%, respectively, at 3 weeks, and 38% and 49%, respectively, at 6 weeks after vaccination. The authors concluded that, despite reduced vaccine response, patients remained capable of producing antibody levels consistent with protection.20 Cladribine Use of live vaccinations is not recommended during treatment, and treatment should not be initiated within 4–6 weeks after live vaccinations. The manufacturer recommends against live vaccination during or after a treatment, until white blood cell counts have normalised.21 Data regarding safety or efficacy of vaccines following treatment are lacking. Live vaccines were prohibited in the placebo‐controlled CLARITY trial.22 Several patients were exposed to non‐live vaccinations with no adverse events reported. The optimal timing of vaccination with regard to treatment, and the impact of cladribine therapy on vaccine efficacy, are not known. Natalizumab Clinical trials and post marketing surveillance data suggest that non‐live vaccinations are safe and effective during treatment. The use of live vaccinations is not recommended during therapy. A phase 4, open label, randomised study measured response to tetanus in natalizumab‐treated patients, all of whom achieved protective levels of tetanus antibodies.23 A study found no statistically significant difference in mean influenza IgG levels between patients receiving natalizumab and healthy controls following vaccination, suggesting maintained humoral immune response.24A study observed reduced long term protection after H1N1 influenza vaccination in natalizumab‐treated patients; the authors suggested the need for two vaccine doses in the setting of an influenza pandemic.4 Alemtuzumab Alemtuzumab treatment should be delayed for 6 weeks following the final dose of a live vaccine. The efficacy of non‐live vaccines during or after alemtuzumab therapy for multiple sclerosis is unclear. One study suggests patients are able to maintain viral immunity following treatment. Data regarding the safety of live vaccines following immune reconstitution are also lacking; this may in theory be safe, especially if T and B cell subsets have normalised. A case–control study observed preserved serological response to diphtheria, tetanus, polio, Haemophilus influenzae, meningococcal C and pneumococcus vaccines in alemtuzumab‐treated patients.25 Pre and post alemtuzumab antibody levels to common viruses (measles–mumps–rubella, varicella zoster and Epstein–Barr) were comparable with historical controls, suggesting pre‐existing immunity does not decline after treatment.25 Data from alemtuzumab used for rheumatoid arthritis suggests that vaccine response to both neoantigens and recall antigens returns to normal and remains normal up to 20 years.26 Ocrelizumab, rituximab Vaccine response in patients receiving anti‐CD20 agents may be attenuated.27 It is therefore recommended that all necessary vaccines be completed before anti‐CD20 treatment. Anti‐CD20 therapy should be delayed for 4–6 weeks following the final dose of a live vaccine. The safety of immunisation with live vaccines following ocrelizumab has not been studied and it is therefore not recommended during treatment and until B cell repletion (which may take up to 72 weeks).28 Ocrelizumab exposure during pregnancy may result in neonatal B cell depletion, which may impact the safety and efficacy of neonatal vaccinations. Monitoring of neonatal CD19 counts is recommended, and vaccines should be administered only after normalisation.28 Following treatment for over 2 years, the proportion of patients with positive antibody titres against pneumococcus, measles–mumps–rubella and varicella zoster virus were similar to baseline, suggesting CD20 B cell depletion does not impact pre‐existing protective viral antibodies.28 A randomised controlled trial investigated the impact of ocrelizumab therapy on response to tetanus, influenza and pneumococcus vaccines. An adequate vaccine response was mounted by all patients but was attenuated in the ocrelizumab group relative to the control group.27

Cassie Nesbitt · Louise Rath · Michael Zhong · Allen C Cheng · Helmut Butzkueven · Robb Wesselingh · Olga Skibina · Mastura Monif · Wei Yeh · Julia ML Brotherton · Stephen Reddel · Anneke Van Der Walt

A 28-year-old woman at 16 weeks’ gestation presented to the emergency department with a 2-day history of severe, worsening left- sided pleuritic chest pain

Rohan V Navani · Claudia Ashkar · Harry Gibbs

A 68-year-old man with diabetes presented with progressive dyspnoea of one month duration

Jeet Ram Kashyap · Aayushi Gupta

The COVID‐19 pandemic has necessitated rapid uptake and use of telehealth, unmasking a number of concerns potentially not previously contemplated by clinicians, patients and legislators In the physical distancing climate of coronavirus disease 2019 (COVID‐19), the ubiquity of virtual communications in medical practice generates a number of challenges. Consultation via telehealth allows for creation of audiovisual documentation of the clinical interaction as well as observation by unseen parties from each participant’s perspective, either in real time or subsequently via review of any recordings. It is necessary for clinicians to i) obtain informed consent for clinician‐led recordings, ii) be aware of potential patient‐generated recordings (both declared and undeclared), and iii) meet legal, privacy and storage requirements pertaining to health information arising from a virtual consultation. Consent to participation Observing next of kin or third parties to a virtual telehealth consultation must be introduced to the treating clinician in a manner consistent with an in‐person consultation, whereby such an individual would, with the patient’s consent, attend the consultation with the patient. In considering the clinician’s screen, consent for clinician participation is implied, but should be specifically broadened where appropriate to allow for the presence of clinical observers. Indeed, the clinician’s duty of confidentiality still applies to telehealth consultations, necessitating awareness of others within earshot or visual proximity to the consultation. Implications of virtual participation The benefits of a virtual consultation include participation and collaboration with members of the patient’s family previously unable to participate, as well as increased access to health care for patients with particular physical challenges or vulnerabilities, including vulnerability to infection with COVID‐19. Interviewing a patient in their home adds rare insights for a clinician not typically engaged in home visits, including opportunities for environmental observation, which may be of clinical value. The home setting allows for involvement of parties (seen and unseen) potentially contrary to the patient’s best interests. Pertinent examples include family violence or elder abuse contexts, where presence of offenders may jeopardise the clinical encounter and may pose direct risks to the patient in the periconsultation period and subsequently via covert audio or video footage. A 2020 article provided insights on screening questions for detecting and navigating potential abuse during telehealth consultations in the setting of a COVID‐19‐related domestic violence epidemic secondary to government‐imposed social restrictions.1 Beyond clinical value, novel forms of documentation (including audiovisual recording) generated within the consultation may benefit research, education, billing and coding, subject to appropriate ethical and consent obligations. The content of a traditional clinical consultation episode is limited to the parties in the room and, to a defined extent, other parties (via review of written documentation). In the telehealth context, a wide audience can potentially review video footage of the consultation, as if they were there, for an indefinite period. This may have implications for the practicalities and duration of storage required of such material, its latent role as discoverable documentary evidence in future litigation (particularly given the persuasive nature of audiovisual documentation), and in substantiation of episodic care funding. Clinical interactions may incorporate questions or discussions that, while appropriate sequentially, may appear inappropriate, deficient, discourteous or misleading if taken out of context or distilled to a single statement or query. Recordings, and their potential edits, could be used by patients in a maladaptive manner, engender abnormal illness behaviour, or make a participant consciously or unconsciously feel the need to perform or otherwise change clinical interactions. Recordings by the patient The likelihood of a patient recording a clinical encounter is much higher in the age of telehealth, when secret recording is increasingly possible. The legality of recording a private conversation without consent depends on the state or territory where the person undertaking the recording resides, as surveillance legislation is largely a matter for these jurisdictions (Box 1). In New South Wales, South Australia, Tasmania, Western Australia and the Australian Capital Territory, it is an offence to record a private conversation. This was upheld in NSW in Toth v Director of Public Prosecutions, where it was held that a patient secretly recording a consultation with a general practitioner was an offence.2 However, in Victoria, Queensland and the Northern Territory, it is lawful to record a private conversation without consent if you are a party to the conversation.3,4,5 In all jurisdictions, it is generally not permissible to publish or communicate information secretly recorded. However, exceptions exist; for example, in Victoria, the prohibition on publication or communication of information secretly recorded does not apply to subsequent use in the course of legal or disciplinary proceedings.6 Courts may be more receptive to the notion of undisclosed recordings for defensive purposes where there is a reasonable belief that a recording might be necessary to address a substantive harm. Thus, in certain jurisdictions, patients can secretly record a consultation without the consent of the clinician and this recording may be used in legal or disciplinary proceedings. These risks are best described as emerging given the widespread use of telehealth and the paucity of reported examples of recording. It should also be stressed that when practitioners are behaving professionally and meeting the appropriate standard of care, the medico‐legal risk of patient recordings is minimal. Practical measures to prevent patients from secretly recording screens include disabling the in‐built recording functions in telehealth platforms, using platforms lacking this recording option, and employing programs preventing screen recording or superimposing watermarks including publication preclusion. However, such measures will not prevent another party from recording a consultation with an additional device. Provision of documented restrictions to the patient at the time of any patient‐generated recording and co‐recording by the clinician (to ensure record integrity) may be of value. However, an automated message before consultation commencement expressly stating the clinician does not consent to screen recording (intending to effect a licence agreement or permit a gag order) is unlikely to achieve this in jurisdictions allowing patients to record without the clinician’s permission. Recordings by the clinician Key to understanding and managing both consent and any recordings is the status of these recordings at law. The definition of health information as defined by the Privacy Act 1988 (Cth) s 6FA is broad, including not only information pertaining to someone’s health but also personal information collected to provide, or in providing, a health service to an individual.7 Interpreted literally, any information pertaining to a patient that is recorded, irrespective of consent, may be considered health information with requirements for storage in compliance with the relevant state or territory health records and/or freedom of information legislation (Box 2). In Australia, under the Privacy Act 1988 (Cth) as well as relevant state and territory legislation, a patient’s medical records will generally be held and owned by the clinician or health care organisation, but patients are entitled to access and take a copy of their records. However, concepts of data sovereignty are changing.8 Patient‐driven and centralised health records (such as collaborative digital hospital files and My Health Record) are contemporary examples of this, with reduced clarity about the roles and responsibilities of potential contributors (including the patient) to a medical record as well as the ownership of that information. Various jurisdictions within Australia legislate minimum periods for medical record‐keeping, generally 7 years from the date of the last record entry for adults and until the age of 25 years for children. Many variations exist, based on state or territory, whether the records reside in a public or private institution, or relate to public health, quality improvement, disability, implants or artificial devices, sexual assault counselling, or child protection. Efficient and safe storage of electronic health information by clinicians, including telehealth recordings, is increasingly challenging. Considerations include provisions regulating onshore versus offshore and cloud‐based storage technicalities, including encryption inherent in the platform of choice, preventing evolving real‐time threats to health information security (including via insurance and strategic risk mitigation), and compliance with legislated security requirements. The omnipresence of personal digital devices, including smartphones, has irrevocably altered the role and prevalence of clinical photography, videography and digital team communication tools, constantly generating much data, not all of which are routinely stored by health services or clinicians relying on them to guide clinical decisions. Clear documentation of consent to recording of digital information by clinicians is important, and that consent should extend to the purpose of the recording. When the patient provides their consent, the use of the recording should be limited to that purpose.9 Recording of telehealth discussions between health care workers, including multidisciplinary meetings and case conferences, engenders further challenges. Recordings may be helpful for updating absent clinicians, minute taking, education or documentation. However, such recordings constitute health information, necessitating compliance with management and storage requirements applicable to a virtual consultation. In the public sector, patients may have access to recordings under freedom of information legislation, potentially resulting in significant alterations to the dynamic and tone of the discussion. This is a complex area of law which varies among jurisdictions but is worth keeping in mind. Where there is uncertainty, proactive discussion with medical indemnity providers may be invaluable, especially given the heterogeneity of legal obligations upon clinicians across jurisdictions. Conclusion In Australia, the COVID‐19 pandemic has necessitated rapid uptake and use of telehealth. This has unmasked a number of concerns potentially not previously contemplated by legislators, patients and clinicians, particularly concerning the recording of clinical consultations and thereby the creation of health information, with extensive associated data management and security compliance challenges. Recording of clinical conversations or processes may enhance patient and clinician participation, self‐reference, research, education and funding. In certain jurisdictions, however, clinical consultations or meetings may be lawfully recorded with or without participants’ knowledge, and may later be accessible to the patient, including for use in future legal or disciplinary proceedings, potentially stifling candid discussion. This and the challenging obligations relating to data management technicalities represent real risks for clinicians and health services. It is incumbent upon health care providers and lawmakers alike to consider these issues in a practical context, ensuring that telehealth is not only a useful tool but a safe and effective one. Box 1 – Legislation governing covert recordings State or territory Legislation pertaining to recording Australian Capital Territory Listening Devices Act 1992 (ACT) New South Wales Surveillance Devices Act 2007 (NSW) Northern Territory Surveillance Devices Act 2007 (NT) Queensland Invasion of Privacy Act 1971 (QLD) South Australia Listening and Surveillance Devices Act 1972 (SA) Tasmania Listening Devices Act 1991 (TAS) Victoria Surveillance Devices Act 1999 (VIC) Western Australia Surveillance Devices Act 1998 (WA) Box 2 – Legislation governing health information management Jurisdiction Legislation governing health information management (not including legislated regulations) Federal Privacy Act 1988 (Cth); Personally Controlled Electronic Health Records (Consequential Amendments) Act 2012 (Cth); My Health Records Act 2012 (Cth); Freedom of Information Act 1982 (Cth) State or territory Australian Capital Territory Health Records (Privacy and Access) Act 1997 (ACT) New South Wales Health Records and Information Privacy Act 2002 (NSW) Northern Territory Health Services Act 2014 (NT); Information Act 2002 (NT) Queensland Information Privacy Act 2009 (QLD); Right to Information Act 2009 (Qld); Public Records Act 2002 (QLD) South Australia Freedom of Information Act 1991 (SA); State Records Act 1997 (SA) Tasmania Personal Information Protection Act 2004 (TAS); Right to Information Act 2009 (TAS) Victoria Health Records Act 2001 (VIC); Privacy and Data Protection Act 2014 (VIC); Freedom of Information Act 1982 (VIC); Public Records Act 1973 (VIC) Western Australia Freedom of Information Act 1992 (WA); State Records Act 2000 (WA)

Caitlin C Farmer · Sam C Pang · Dev Kevat · Jessica Dean · Danielle Panaccio · Patrick D Mahar

In the absence of evidence of benefit for acute low back pain, its over-the-counter availability should be reconsidered

Chris Hayes · Jennifer H Martin

Until we reach “prevalence equilibrium”, even small increases in incidence eventually result in higher prevalence When I attended medical school in the 1980s, we were taught that ulcerative colitis and Crohn disease were conditions seen in white people in highly developed regions such as northern Europe, the United Kingdom and some Commonwealth nations, and North America. Over the past four decades, the incidence of inflammatory bowel disease (IBD) across geographic regions and ethnic groups has risen sharply.1 The global burden of IBD, which can substantially reduce quality of life, is clearly increasing.2 Patients with IBD often require expensive medications or procedures,3 have higher rates of anxiety and depression,4 and are more likely to have disabilities.5 The prevalence of a chronic disease (number of new and old cases per number of persons) roughly corresponds to the incidence (number of new cases per person‐years) multiplied by the mean duration of the condition.6 For IBD, for which the median age at diagnosis is 30–35 years7 and life expectancy is normal or near normal,8 the prevalence will ultimately be 30 to 50 times the incidence rate. Consequently, even small increases in incidence will eventually result in higher prevalence, especially when the incidence rate is higher than the mortality rate. This concept of “compounding prevalence” has only recently been applied to IBD,9 but it is an extremely accurate description. We are now seeing these effects in several areas of the world. In Canada, the prevalence of IBD may be as high as 700 cases per 100 000 population;10 the prevalence may be even higher in the Lothian region of Scotland, where it is estimated to exceed 800 cases per 100 000 population and is projected to rise over the next eight years to more than 1200 per 100 000.11 To put this into context, the global age‐standardised prevalence of IBD in 2017 was estimated to be 84.3 cases per 100 000 population.2 The high prevalence of IBD in the City of Canada Bay in metropolitan Sydney described in this issue of the MJA by Pudipeddi and colleagues12 fits this pattern. The reported overall age‐standardised prevalence of about 350 cases per 100 000 population means that 1 in 280 people in this region has ulcerative colitis or Crohn disease, and prevalence rises with age, to roughly 1 in 160 people aged 65 years or more. On the basis of their findings, the authors estimate that more than 81 000 Australians have IBD. Most patients with IBD are diagnosed before the age of 40 years. Higher prevalence in older people may be partly explained by the inverse epidemiological association between cigarette smoking and ulcerative colitis, one of the few conditions against which cigarette smoking is seemingly protective;13 most patients with ulcerative colitis are never or former smokers. In Olmsted County, Minnesota, for example, mortality among patients with ulcerative colitis is actually lower than for the general population, as any increase in deaths related to gastrointestinal causes or cancers is more than offset by lower cardiovascular mortality.8 This consideration would, however, not apply to Crohn disease. We must also remember that the typical patient with IBD is diagnosed in their 20s or 30s, but more than one‐third of people with Crohn disease and 40% of those with ulcerative colitis are diagnosed after the age of 40 years.7 In fact, the age at diagnosis in Olmsted County and some other regions has a bimodal distribution, with a second peak in incidence later in life,8 although some diagnostic confusion — older people with diverticulitis or ischaemic colitis being diagnosed with IBD — is possible.14 Another explanation for increasing prevalence with age in the study by Pudipeddi and colleagues may be the ethnic makeup of suburban Sydney, in which more than 15% of residents are Asian.12 Studies in Asian countries have reported higher median ages at IBD diagnosis.15,16 Why is the higher prevalence of IBD among older people important? Although some studies have suggested a milder disease course for those diagnosed with IBD later in life,17 they comprise only a minority of older people with IBD; in the Canada Bay study, only 25% of patients with IBD had been diagnosed after the age of 48 years.12 Older patients with IBD can be more difficult to manage, as they are two to three times as likely to have serious infections after treatment with biologics,18 and post‐operative morbidity and mortality are significantly more likely than for younger or middle‐aged adults.19 Older patients are also more likely to meet the definition of “frailty”, itself associated with higher rates of serious adverse events during immunosuppressive therapy,20 and mortality and re‐admission rates for hospitalised patients with IBD are higher.21 I agree with the recommendation by Pudipeddi and his colleagues to consider non‐systemic immunosuppressive therapies when possible. Until we reach “prevalence equilibrium”22 — that is, when prevalence stabilises because the overall mortality rate is equal to the incidence rate — physicians and health authorities need to continue adjusting to the increasing burden of IBD.

Edward V Loftus

Australia has a once-in-a-lifetime opportunity to create a healthy, sustainable, equitable and prosperous future by taking bold action to build back better, fairer and greener after the coronavirus pandemic

Sandro Demaio

Objectives: To determine the age‐standardised prevalence of inflammatory bowel disease (IBD) in a metropolitan area of Sydney, with a focus on its prevalence among older people. Design, setting: Population‐based epidemiological study of people with IBD in the City of Canada Bay, a local government area in the inner west of Sydney, during 1 March 2016 – 10 November 2016. Participants: Patients diagnosed with confirmed IBD according to the Copenhagen or revised Porto criteria. Main outcome measures: Crude prevalence of IBD, including Crohn disease and ulcerative colitis; age‐standardised prevalence of IBD, based on the World Health Organization standard population; prevalence rates among people aged 65 years or more. Results: The median age of 364 people with IBD was 47 years (IQR, 34–62 years); 185 were women (50.8%). The crude IBD prevalence rate was 414 cases (95% CI, 371–456 cases) per 100 000 population; the age‐standardised rate was 348 cases (95% CI, 312–385 cases) per 100 000 population. The age‐standardised rate for Crohn disease was 166 cases (95% CI, 141–192 cases) per 100 000 population; for ulcerative colitis, 148 cases (95% CI, 124–171 cases) per 100 000 population. The IBD prevalence rate in people aged 65 years or more was 612 cases (95% CI, 564–660 cases) per 100 000, and for those aged 85 years or more, 891 cases (95% CI, 833–949 cases) per 100 000; for people under 65, the rate was 380 cases (95% CI, 342–418 cases) per 100 000. Conclusions: We found that the prevalence of confirmed IBD in a metropolitan sample was highest among older people. Challenges for managing older patients with IBD include higher rates of comorbid conditions, polypharmacy, and cognitive decline, and the immunosuppressive nature of standard therapies for IBD.

Aviv Pudipeddi · Jeffrey Liu · Viraj Kariyawasam · Thomas J Borody · James L Cowlishaw · Charles McDonald · Peter Katelaris · Grace Chapman · Crispin Corte · Daniel A Lemberg · Cheng H Lee · Anil Keshava · John Napoli · Robert Clancy · Webber Chan · Sudarshan Paramsothy · Rupert Leong

Objective: To assess the analgesic efficacy and safety of single‐dose oral cannabidiol (CBD) as an adjunct to standard care for patients presenting to an emergency department with acute low back pain. Design: Randomised, double blinded, placebo‐controlled clinical trial. Setting: The tertiary emergency department of Austin Hospital, Melbourne. Participants: Patients who presented with acute, non‐traumatic low back pain between 21 May 2018 and 13 June 2019. Intervention: One hundred eligible patients were randomised to receiving 400 mg CBD or placebo in addition to standard emergency department analgesic medication. Main outcome measures: Pain score two hours after administration of study agent, on a verbal numerical pain scale (range, 0‒10). Secondary outcomes were length of stay, need for rescue analgesia, and adverse events. Results: The median age of the 100 participants was 47 years (IQR, 34‒60 years); 44 were women. Mean pain scores at two hours were similar for the CBD (6.2 points; 95% CI, 5.5–6.9 points) and placebo groups (5.8 points; 95% CI, 5.1–6.6 points; absolute difference, –0.3 points; 95% CI, –1.3 to 0.6 points). The median length of stay was 9.0 hours (IQR, 7.4‒12 hours) for the CBD group and 8.5 hours (IQR, 6.5‒21 hours) for the placebo group. Oxycodone use during the four hours preceding and the four hours after receiving CBD or placebo was similar for the two groups, as were reported side effects. Conclusion: CBD was not superior to placebo as an adjunct medication for relieving acute non‐traumatic low back pain in the emergency department. Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12618000487213 (prospective).

Bronwyn Bebee · David M Taylor · Elyssia Bourke · Kimberley Pollack · Lian Foster · Michael Ching · Anselm Wong

In June 2015, 41% of Australian medical specialists were women,1 but only 28% of those in senior or leadership positions.2 Academic research is important for obtaining tenure and promotion in medicine. First authorship on publications is typically granted to junior authors and last authorship to directing senior authors. The proportion of women among first authors in six prominent American medical journals increased from 5.9% in 1970 to 29.3% in 2004, and for last authorship from 3.7% to 19.3%.3 However, a 2016 study found that the proportion of authors who were women in high impact medical journals had plateaued or declined since 2009.4 Examining Australian patterns of authorship could help identify barriers to the academic advancement of women in medicine. We identified in PubMed all journal articles published during 2005–2018 by the eight journals associated with peak bodies of Australian medical practitioners, and used the validated genderize. R tool to determine the probable gender of authors’ first names.5 We used Poisson regression to analyse first and last authorship (male = 0, female = 1) by year; we report the statistical significance of the deviation of the regression slope (B‐value) from zero. The relationship between number of authors and gender were assessed by linear regression, including an interaction term between gender and time. Formal ethics approval was not required for this analysis of publicly available data. Gender could be determined with at least 50% probability for the first authors of 26 621 of 27 804 articles (96%) and the last authors of 26 972 (97%). Between 2005 and 2018, the proportion of women among first authors in the eight journals increased from 522 of 1600 (32.6%) to 899 of 2391 (37.6%; P < 0.001); the proportion among last authors did not change (28.0%). The proportions of women among both first and last authors increased significantly in the Journal of Paediatrics and Child Health, the Australian and New Zealand Journal of Obstetrics and Gynaecology, and the Medical Journal of Australia, as did those of first authors (but not last authors) in the Australian and New Zealand Journal of Public Health, Emergency Medicine Australasia, the Australian and New Zealand Journal of Psychiatry, and the Australian and New Zealand Journal of Surgery; the proportions of neither changed significantly in Australian Family Physician (Box; Supporting Information, table 1). The mean number of authors on publications with women as first authors (3.8; standard deviation [SD], 2.4) was higher than for those with men as first authors (3.3; SD, 2.4; P < 0.001). The difference between author numbers was smaller, but statistically significant, with respect to last author gender (women: mean number of authors, 3.6; SD, 2.4; men: 3.5; SD, 2.4; P = 0.045) (Supporting Information, tables 2, 3). Our study did not distinguish between research, review, and other journal article types. While our findings may reflect overall involvement of women in research, they do not specifically define gender proportions among leaders of high impact academic research programs. The increase in the proportion of first authors of Australian medical journal articles who are women may reflect the rise in the proportion of female doctors from 33% to 43% between January 2006 and December 2018.1 It is also possible that women, under‐represented in their specialties, feel greater pressure than men to publish as first authors for purposes of career progression.2 Our data indicate that the proportion of women as first authors has increased, but that of last authorship has grown only in some specialities. Box – Proportions of women as first and last authors of articles in selected Australian medical journals, 2005–2018* * The raw data are included in the online Supporting Information, tables 4 and 5. † From 2018: the Australian Journal of General Practice.

Matthew J Lennon · Rose Kennedy · Hannah Ryan · Dennis R Neuen · Melissa Godwin

In Australia, an estimated 12.7% of patients with ST‐elevation myocardial infarction (STEMI) die or have recurrent myocardial infarctions within 30 days of diagnosis.1 Prompt reperfusion reduces morbidity and mortality, and guidelines consequently aim to minimise the time between symptom onset and reperfusion.1,2,3 Patients with chest pain may arrange their own transport to an emergency department or travel by ambulance. The risk period is shorter for patients without access to a defibrillator when they travel by ambulance, and they receive initial management more promptly. In Australia, only one in two patients with STEMI calls an ambulance.4 Characterising patients less likely to call an ambulance would inform targeted public health efforts to improve this situation. We analysed data contributed by 43 hospitals across Australia to the Cooperative National Registry of Acute Coronary Care, Guideline Adherence and Clinical Events (CONCORDANCE)5 for patients with confirmed STEMI who presented to these hospitals during 23 February 2009 – 31 December 2017. We excluded patients who experienced out‐of‐hospital cardiac arrest or cardiogenic shock. We compared the clinical characteristics, time to reperfusion, and hospital outcomes, including death and major adverse cardiovascular events (MACE) — cardiac death, myocardial infarction, heart failure, or shock — for patients who arrived by ambulance or otherwise, after adjusting for Global Registry of Acute Coronary Events (GRACE) risk score6 at baseline. The statistical significance of differences in categorical variables was assessed in Rao–Scott χ2 tests and that of continuous variables in Wilcoxon rank‐sum tests. For adjusted analyses, we used multivariable logistic regression models in a generalised estimating equation (GEE) framework, adjusted for clustering by hospital. Analyses were conducted in SAS 9.4. Ethics approval for the study was granted by the Concord Repatriation General Hospital Human Research Ethics Committee (reference, HREC/08/CRGH/180). Of 2765 patients who presented with STEMI to CONCORDANCE hospitals during 2009–2017, 1616 (58.4%) arrived by ambulance and 1149 (41.6%) by other means. The median age of patients arriving by ambulance (64 years; interquartile range [IQR], 54–74 years) was higher than for the other patients (59 years; IQR, 51–67 years), and the proportions with hypertension, a family history of coronary heart disease, or prior myocardial infarction, atrial fibrillation, or stroke/transient ischaemic attack were larger (Box). Time between arrival at hospital and reperfusion (primary percutaneous intervention or fibrinolysis) was significantly shorter for patients who arrived by ambulance than for other patients (Box). After adjusting for GRACE risk score, the odds of death (adjusted odds ratio [aOR], 1.16; 95% confidence interval [CI], 0.65–2.08) and MACE (aOR, 0.89; 95% CI, 0.72–1.10) were similar for the two patient groups (Supporting Information). Our analysis of data from a large Australian registry indicates that fewer than 60% of patients with STEMI arrive at hospital by ambulance; those who do have a higher median age and larger proportions have histories of cardiovascular disease. Importantly, their median time to reperfusion is shorter than for those not arriving by ambulance, probably because STEMI is diagnosed by electrocardiography during their journey to the hospital, which facilitates priming of emergency departments (for fibrinolysis) and catheterisation laboratories (for percutaneous coronary intervention). Despite the less favourable risk profiles of patients who arrive by ambulance, their hospital outcomes are comparable with those of patients who present directly to hospital, presumably because of their more rapid access to reperfusion. Our finding that patients with STEMI who are older and have more comorbid conditions are more likely to call an ambulance is not novel,7 but does indicate that this has not changed in recent years. This underscores the value of calling an ambulance when chest pain develops, and suggest that this public health message should be more actively promoted. Box – Baseline characteristics and times to reperfusion of 2765 patients who presented with STEMI to CONCORDANCE hospitals, 2009–2017 table#t1 tbody td:nth-child(n+2) P. Pleft { text-align: center; } Transport to hospital Characteristic Ambulance Other means P Number of patients 1616 (58.4%) 1149 (41.6%) Age (years), median (IQR) 64 (54‒74) 59 (51‒67) < 0.001 Sex (men) 1140 (71%) 933 (81%) < 0.001 English as first language 1383 (86%) 959 (83%) 0.44 Prior myocardial infarction 252 (16%) 151 (13%) 0.046 Prior heart failure 49 (3%) 27 (2%) 0.27 Prior percutaneous coronary intervention 177 (11%) 116 (10%) 0.46 Prior coronary artery bypass graft 52 (3%) 26 (2%) 0.10 Prior atrial fibrillation 96 (6%) 30 (3%) < 0.001 Prior bleeding 17 (1%) 14 (1%) 0.63 Chronic renal failure 73 (5%) 42 (4%) 0.17 Prior stroke/transient ischaemic attack 94 (6%) 32 (3%) < 0.001 Diabetes 321 (20%) 232 (20%) 0.80 Hypertension 853 (53%) 534 (47%) < 0.001 Dyslipidaemia 696 (43%) 473 (41%) 0.21 Family history of coronary heart disease 514 (32%) 477 (42%) < 0.001 Grace risk score (Fox), median (IQR) 114 (95‒135) 102 (85‒119) < 0.001 Reperfusion modality Primary percutaneous coronary intervention 919 (57%) 486 (42%) < 0.001 Fibrinolysis 434 (27%) 442 (38%) < 0.001 None 320 (20%) 273 (24%) 0.010 Hospital arrival to reperfusion (h), median (IQR) Primary percutaneous coronary intervention 1.2 (0.7‒2.1) 2.1 (1.4‒6.1) < 0.001 Fibrinolysis 0.6 (0.3‒1.3) 0.8 (0.5‒1.3) 0.002 IQR = interquartile range; STEMI = ST‐elevation myocardial infarction.

Eleanor Redwood · Karice Hyun · John K French · Leonard Kritharides · Mark Ryan · Derek P Chew · Mario D'Souza · David B Brieger

Objective: To assess the association between having a serious mental illness and surgical outcomes for adults, including in‐hospital and 30‐day mortality, post‐operative complications, and hospital length of stay. Study design: Systematic review and meta‐analysis of publications in English to 30 July 2018 of studies that examined associations between having a serious mental illness and surgical outcomes for adults who underwent elective surgery. Primary outcomes were in‐hospital and 30‐day mortality, post‐operative complications, and length of hospital stay. Risk of bias was assessed with the Quality in Prognosis Studies (QUIPS) tool. Studies were grouped by serious mental illness diagnosis and outcome measures. Odds ratios (ORs) or mean differences (MDs), with 95% confidence intervals (CIs), were calculated in random effects models to provide pooled effect estimates. Data sources: MEDLINE, EMBASE, PsychINFO, and the Cochrane Library. Data synthesis: Of the 3824 publications identified by our search, 26 (including 6 129 806 unique patients) were included in our analysis. The associations between having any serious mental illness diagnosis and having any post‐operative complication (ten studies, 125 624 patients; pooled effect: OR, 1.44; 95% CI, 1.15–1.79) and a longer stay in hospital (ten studies, 5 385 970 patients; MD, 2.6 days; 95% CI, 0.8–4.4 days) were statistically significant, but not those for in‐hospital mortality (three studies, 42 926 patients; OR, 1.21; 95% CI, 0.69–2.12) or 30‐day mortality (six studies, 83 013 patients; OR, 1.85; 95% CI, 0.86–3.99). Conclusions: Having a serious mental illness is associated with higher rates of post‐operative complications and longer stays in hospital, but not with higher in‐hospital or 30‐day mortality. Targeted pre‐operative interventions may improve surgical outcomes for these vulnerable patients. Systematic review registration: PROSPERO, CRD42018080114 (prospective).

Kate E McBride · Michael J Solomon · Paul G Bannon · Nicholas Glozier · Daniel Steffens

To the Editor: Modelling commissioned by the federal government estimates that the fertility rate in Australia will drop to an all‐time low of 1.59 babies per woman in 2020–21.1 However, anecdotal observation suggests this projection does not reflect the apparent increase in current bookings for antenatal appointments in our (public) practice. Therefore, we reviewed the use of the five Medicare Benefits Schedule (MBS) item numbers for “microbiological serology during a pregnancy” (ie, 69405, 69408, 69411, 69413 and 69415), as one of these numbers is usually billed at the first antenatal visit. In June 2020, the use of these item numbers increased by 25.4% and later declined to a 9.6% increase in September 2020 compared with September 2019 (Box).2 In the period from 2018 up to the start of the coronavirus disease 2019 (COVID‐19) pandemic, the mean fluctuation in billing volume in the same months over different years was about 3% less or more.2 Therefore, the larger than expected surge in antenatal serology orders since the start of the COVID‐19 pandemic likely represents a significant change in behaviour. Furthermore, this increase in serology testing is on the background of an approximate 3% decline in services for pathology tests not related to COVID‐19 from June to September 2020 compared with the same period in 2019.2 Using MBS item numbers as a surrogate for pregnancy‐related appointment bookings has limitations. In general, women accessing public hospital care may have serology tests done as part of state government funding schemes whereby no MBS item is generated. We cannot exclude the possibility that, in the context of changes related to the COVID‐19 pandemic and a move to telehealth, a higher proportion of women may have had pathology tests done via Medicare. However, it would be expected that if fertility were declining, there would have been a reduction in testing. Furthermore, we were unable to exclude repeat testing, although our experience indicates this would account for an insignificant number of tests. This historical trend, and its context in the timing of an apparent “baby boom” (ie, antenatal serology testing is usually done at around 6–10 weeks’ pregnancy), correlates with an increase in conception starting in late March to early April 2020, during the so‐called first wave of COVID‐19 in Australia. Requests for antenatal serology testing increased by 12 869 from June to September 2020 compared with the same period in 2019 (Box). Factoring in miscarriages, this may mean there will be an additional 11 000 Australian babies born in the third quarter of the financial year 2020–21 compared with the same period in the previous financial year. We believe it is unlikely that fertility rates will drop in 2020–21. Box – Combined Medicare Benefits Schedule (MBS) services for item numbers 69405, 69408, 69411, 69413 and 69415 Month Number of MBS services Variation 2019 2020 June 21 883 27 441 +25.4% July 23 867 26 935 +12.9% August 25 118 27 055 +7.7% September 23 929 26 235 +9.6% Total 94 797 107 666 +13.6%

Len Moaven · James Brown

To the Editor: The coronavirus disease 2019 (COVID‐19) pandemic has created an unprecedented need for real‐time surveillance data to inform decisions and action by public health responders and primary health care practitioners. Early in the pandemic, many countries swiftly produced interactive national dashboards with mapping capabilities.1,2 A dashboard is an online tool for data management which optimises information access and data visualisation.3 Dashboards provide benefits compared with standard reporting, including sharing near real‐time data during rapidly evolving situations, and providing users with the opportunity to interact with the data. If designed appropriately, users can also interrogate data and ask questions based on their specific informational needs. Many dashboards also provide mapping capabilities, allowing for visualisation of spatial distribution of information, and monitoring trends geographically over time.2 Australia does not yet have an official and publicly accessible national interactive dashboard for COVID‐19. Some states and territories have developed publicly available COVID‐19 dashboards, but data are generally aggregated, making it difficult to answer specific questions that include time and location and source of infection. An interactive near real‐time dashboard could improve access to and comprehension of data for primary health care providers and public health responders. Researchers from the Australian National University, Menzies School of Health Research and the University of Queensland are developing a COVID‐19 Real‐time Information System for Preparedness and Epidemic Response (CRISPER) (https://crisper-graphc.hub.arcgis.com/) as a nationwide information and visualisation system for Australia. CRISPER aims to become the principal source of accurate, reliable and spatially explicit real‐time information for COVID‐19 (Box). The system currently uses publicly available postcode‐level data, primarily from state and territory health department websites. Gaining access to nationwide line‐listed data is underway, which will allow additional functionality, including a clinical dashboard detailing clinical outcomes (eg, hospital and intensive care unit admissions, deaths) stratified by demographics, comorbidities, time and place. Also under development is an automatic alert system providing registered users with daily or weekly email alerts on new cases, contract tracing alerts and/or testing rates based on user‐defined geographical areas of interest. We believe that CRISPER will improve accessibility of information for primary health care practitioners and public health responders and will enable them to make more timely and informed decisions. This system may serve as a prototype platform for rapid information sharing for other epidemic‐prone diseases. Box – Features of the Coronavirus Disease 2019 (COVID‐19) Real‐time Information System for Preparedness and Epidemic Response (CRISPER) CRISPER aims to optimise information access and visualisation for COVID‐19 through: a national summaries dashboard detailing cases, deaths and testing — information can be filtered or summarised by states and territories, time periods, and 7‐ or 14‐day rolling averages (https://graphc.maps.arcgis.com/apps/opsdashboard/index.html#/465d9e0cd44247b488b8431a56691417); and an interactive mapping tool of cases, testing and contact tracing alerts by location (postcode, local government areas, public health units) — information can be filtered by time periods and source of infection (currently available for New South Wales). A key feature distinguishing this tool from other dashboards is that the data in the different components are linked; for example, the epidemic curve is dynamic based on cases in the map window (https://graphc.maps.arcgis.com/apps/opsdashboard/index.html#/74e69c2ab40f41c892a652e95373622c)

Emma Field · Amalie Dyda · Colleen L Lau

To the Editor: We thank the MJA for highlighting the fit testing of N95 or P2 respirators in Australian health care workers. Regli and colleagues1 make a compelling case that mandatory fit testing should be implemented in Australian hospitals for frontline staff, in line with South Australian guidelines.2 We note that NSW Health has recently implemented mandatory fit testing in high risk areas.3 We commend these efforts, but they may have important implications that would need planning and consideration in implementation. First, it is clear that anatomical variation of the nasal and malar regions means that some health care workers will only pass the fit tests with particular N95 or P2 respirators.4 This means that along with the implementation of a fit testing program, inventory management systems are also required to facilitate hospital tracking of stocks of particular respirator types and to ensure that sufficient stock is available in high risk areas for individual health care workers. At the Southern Adelaide Local Health Network, we have implemented such a system, which tracks stock levels of all available respirators within the hospital so that key workers who can use only specific types of N95 or P2 respirators will have access to the right type of mask when needed. Second, the coronavirus disease 2019 (COVID‐19) pandemic has disrupted global supply chains, affecting the availability of N95 and P2 respirators. Moreover, fit testing is not a one‐off process, but must be conducted as a rolling program to ensure that all workers have access to appropriately fitting N95 or P2 respirators. Finally, even with an efficient fit testing program, due to anatomical variations, there will always be a proportion of health care workers for whom no masks will be suitable. Along with fit testing, health departments should prioritise health care worker redeployment policies and the development of new technologies to address the needs of the proportion of the workforce with ongoing fit test failure.

Anand Ganesan · Jane Parker · Darius Chapman

To the Editor: In an article on the Human Rights Act 2019 passed by the Parliament of Queensland, Brolan1 noted the Act was “historic but not without challenge”. This challenge is manifest in the case of prisoners. In 2007, the Queensland Coroner recommended prisoners have access to clean injecting equipment.2 We described in 2009 the threat to prisoners’ health of ongoing breaches in infection control,3 which was later evident in the cluster of coronavirus disease 2019 (COVID‐19) cases in the Wacol Youth Detention Centre in Brisbane. In 2018, The Medical Journal of Australia documented the precarious state of harm minimisation in Australia’s prisons. With reference to Queensland, there was only mention to the elimination of hepatitis C infection from one prison and the fact that opiate replacement therapy was not available to all prisoners.4 Furthermore, despite some initial success to improve hepatitis C infection rates among Queensland prisoners,5 they have gone backwards, with reportedly high rates of post‐treatment reinfection in Queensland prisons. How is it possible that Queensland continues to stand out as a model of health service deprivation? Evidence that opiate replacement therapy can be life‐saving for prisoners is conclusive.6 Human rights are universal. The right to health provision and health protection cannot be, and in fact has not yet been, effectively negotiated for or by the community’s most disempowered individuals. Despite human rights protections since 2004, the Australian Capital Territory’s dismal experience7 challenges not just Queensland but all Australians.

Michael Levy · Daniel Mogg

In reply

Claire E Brolan · Erin Cameron · Grazia Catalano

To the Editor: In their observational study, Kimmel and colleagues1 examined the impact of inpatient rehabilitation (IPR) for isolated lower limb injuries on functional outcomes in working‐aged people using inverse probability of treatment weighting (IPTW) propensity score analysis. It concerns us that the study lacks real clinical perspectives in disability management. Firstly, the authors assumed exchangeability in the baseline characteristics of patients discharged home and patients admitted to IPR. Exchangeability of the samples is a prerequisite for IPTW propensity score analysis.2,3 However, this is a flawed assumption in the Australasian context, where patients discharged home are medically stable, have minimal physical disability and have sufficient psychological coping skills. In contrast, patients admitted to IPR are deemed unsafe to be discharged home, with greater disability, home hazards, or inadequate support. IPR addresses complex therapy and care needs while alleviating pressure on acute beds. Secondly, the study examined disability and returning to work without considering all relevant determinants of health and functioning as listed in the World Health Organization’s International Classification of Functioning, Disability and Health. Rather than IPR resulting in a poorer functional outcome through hospital‐related complications, it is our experience that persons who require IPR will have a higher physical, functional, psychological, personal and social complexity or vulnerability, which may result in the observed long term disability. Thirdly, the study identified adverse 12‐month outcomes in patients discharged home. This control group were physically and functionally fit for discharge home, but 67% reported suboptimal recovery on the extended Glasgow Outcomes Scale (GOS‐E) and 16% failed to return to work at 12‐month follow‐up. Given that return to previous jobs plateaus by 6–12 months,4 gaps in care may aggravate problems by preventing timely access to multidisciplinary interventions to address the medical, psychological, physical, occupational and social impact of a traumatic injury. Finally, we encourage the authors to present the 12‐month follow‐up data in the Victorian Orthopaedic Trauma Outcomes Registry (VOTOR) for pain scores, anxiety and/or depression, and other domains of the EuroQol EQ‐5D‐3L Scale.4 Pain perception and depressive symptoms are known predictors for functioning and returning to work following an orthopaedic trauma and likely confounded the results.5

Pearl Chung · Mark Haran

In reply

Lara A Kimmel · Jessica Kasza · Belinda J Gabbe