Medical Journal of Australia最新文献

{"title":"Improving the uptake of highly effective contraception by women using teratogenic medications","authors":"Sarah Donald","doi":"10.5694/mja2.52445","DOIUrl":"10.5694/mja2.52445","url":null,"abstract":"<p>On any given day, more than 30% of Australian women aged 20–40 years take at least one medication subsidised by the Pharmaceutical Benefits Scheme (PBS), and about half these women take more than one.<span><sup>1</sup></span> Of concern for this age group is that almost one-half of pregnancies in Australia are unplanned,<span><sup>2</sup></span> and an unintended pregnancy may only be recognised after the fetus has been exposed to a medication. Consequently, guidelines recommend that highly effective contraceptive measures should be taken by all women of reproductive age during treatment with teratogenic medications and for an appropriate period after their discontinuation.<span><sup>3</sup></span> Long-acting reversible contraception (LARC) is considered very effective, with a failure rate below 1%.<span><sup>4</sup></span></p><p>In this issue of the <i>MJA</i>, Grzeskowiak and colleagues<span><sup>5</sup></span> describe the findings of their retrospective cohort study of the concurrent use of hormonal contraception by women of reproductive age prescribed medicines that are known teratogens (ie, classified as category X by the Therapeutic Goods Administration). Analysing the PBS 10% sample of dispensing data for subsidised medications, the authors found that the rate of dispensing of category X medications to women aged 15–49 years rose from 4.63 per 1000 women in 2013 to 8.70 per 1000 in 2021, predominantly because of increased dispensing of isotretinoin. At the time of their first category X medication dispensing, fewer than one-quarter of women (22.1%) were using any form of hormonal contraception (including oral contraceptives), and only 13.2% were using the more effective hormonal LARC. Among those for whom repeated category X dispensing was recorded, 16.1% had been dispensed a hormonal contraceptive and 11.5% had been dispensed LARC at each category X dispensing.<span><sup>5</sup></span></p><p>The analysis by Grzeskowiak and colleagues of the national dispensing data sample provides a representative picture of contemporary dispensing of category X medications to women of reproductive age in Australia, and their findings indicate that their concurrent use of hormonal contraception is inadequate. One of the main limitations of the study is that one form of LARC, the copper intrauterine device (IUD), is not subsidised by the PBS, nor are several hormonal oral contraceptives that are frequently used in Australia.<span><sup>6</sup></span> It is therefore likely that the authors underestimated the use of contraception. Although contraceptive overlap was analysed by age, health care concession card status, and state/territory, ethnic background is not included in the PBS data, so that more complete examination of the equity aspects of contraceptive overlap was not possible.</p><p>Despite the limitations of the dataset, contraception among women using teratogenic medications is probably unacceptably low. An expert roundtable identified obstacl","PeriodicalId":18214,"journal":{"name":"Medical Journal of Australia","volume":"221 7","pages":"365-366"},"PeriodicalIF":6.7,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.5694/mja2.52445","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142290487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Policy influential research: setting, informing and decoding our national health and social policy agenda and activities","authors":"Maria Inacio","doi":"10.5694/mja2.52431","DOIUrl":"https://doi.org/10.5694/mja2.52431","url":null,"abstract":"<p>The <i>MJA</i> aims to prioritise studies that will “advance knowledge or practice with respect to medical problems of significance for Australia”. This is particularly inclusive of studies that not only have the potential to affect clinical practice, but also to help set, inform and improve our national health and social policies. In this issue of the <i>MJA</i>, we showcase several studies that have and will continue to inform national policy, help us understand how evidence can be used to best effect in the health policy process, and remind us of how and what is being done about other important national policy priorities.</p><p>Australia's journey in regulating vaping, a relatively recent yet significant public health threat, especially to younger people, has taken a positive turn this year. The <i>Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024</i> took effect in July 2024 and significant more regulation to access, packaging, and formulations of vapes was introduced nationally (https://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/bd/bd2324a/24bd061a). These changes are internationally recognised as bold attempts at curbing vaping among younger people and have been influenced by an enormous body of work and advocacy. It is work such as Jenkins and colleagues’ (https://doi.org/10.5694/mja2.52423) in this issue, which identified a synthetic nicotine analogue (6-methylnicotine) in “non-nicotine” vapes and accompanying inconsistent chemical reporting, that are the pillars of evidence required to inform our national legislative journey. As noted by Larcombe and Hunter (https://doi.org/10.5694/mja2.52422) in an accompanying editorial, loopholes in legislation will continue to be used by vape manufacturers and our regulatory bodies must keep up, or ideally get in front of their attempts at circumventing them using evidence like that presented by Jenkins and colleagues.</p><p>This issue of the <i>MJA</i> also includes a compendium piece for readers of modelled economic evaluations by Chen and colleagues (https://doi.org/10.5694/mja2.52409). Economic evaluations are ubiquitous and critical to how Australia makes decisions about medicines, devices, and other health care services (https://www.sciencedirect.com/science/article/pii/S221210992030666X), yet not always clearly accessible to non-health economist readers. Chen et al remind us that with more complex questions, interventions, heterogenous populations, and luckily more computational power, more sophisticated model-based economic evaluations are required, unavoidable, and our understanding of them must evolve. Using two recent <i>MJA</i> studies as examples (https://doi.org/10.5694/mja2.51825, https://doi.org/10.5694/mja2.51860), Chen et al describe how model-based evaluations compare to study-based evaluation, major modelling choices with powerful visual representations of these models and advice on what to look out for when determining model robustness.</","PeriodicalId":18214,"journal":{"name":"Medical Journal of Australia","volume":"221 6","pages":"289"},"PeriodicalIF":6.7,"publicationDate":"2024-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.5694/mja2.52431","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142234002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intimate partner violence and reproductive coercion: cross-sectional study of women attending a Perth sexual health clinic, 2019–20","authors":"Mariana Galrao, Catherine B Brooker, Alison Creagh, Richelle Douglas, Sarah Smith","doi":"10.5694/mja2.52436","DOIUrl":"10.5694/mja2.52436","url":null,"abstract":"<p>Intimate partner violence and reproductive coercion have important negative mental and physical health effects.<span><sup>1</sup></span> Without a standardised data collection system, ascertaining the prevalence of these forms of abuse is difficult in Australia, but this information is crucial for decision makers designing evidence-based measures at the national, state, and local levels.</p><p>We therefore undertook a cross-sectional study of relationships between selected demographic characteristics and reported exposure to violence, based on data collected in printed screening questionnaires (Supporting Information) and from patient electronic medical records for women (self-identified) aged 16 years or older who attended the Sexual Health Quarters clinic (SHQ; https://shq.org.au) between 1 March 2019 and 31 March 2020. We have described the development, implementation, and impact of the clinic screening program elsewhere.<span><sup>2</sup></span> Written informed consent was provided by each participant, and they completed questionnaires in a private area of the clinic waiting room. The following information was extracted from participants’ medical records in the SHQ clinical database: age, country of birth, postcode, date of screening, Indigenous status, sex of intimate partners, SHQ attendances prior to screening, screening and brief risk assessment responses, and the date of any counselling appointments. Socio-economic status was based on the 2016 Socio-Economic Indexes for Areas (SEIFA) Index of Relative Socioeconomic Disadvantage (IRSD) decile for residential postcode at the time of screening.<span><sup>3</sup></span> We summarise characteristics as descriptive statistics, and assessed relationships between these characteristics and reported exposure to intimate partner violence (lifetime or current exposure) in multivariate logistic regression analyses; we report prevalence odds ratios (PORs) with 95% confidence intervals (CIs). Statistical analyses were undertaken in Stata 15. The University of Western Australia Human Research Ethics Committee approved the study (RA/4/20/4896).</p><p>Of 3745 eligible women, 2623 (70%) participated in the study (Box 1); we regarded them as representative of all women who attended the clinic. In their screening questionnaires, 454 participants (17.3%) reported they had experienced intimate partner violence (427, 16.3%) or reproductive coercion (139, 5.3%) at some point in their life. Ninety-one participants (3.5%) reported abuse in their current relationship: 85 reported intimate partner violence (3.2%), 38 reproductive coercion (1.4%). The proportion of women who reported current intimate partner violence was larger for respondents who reported reproductive coercion than for those who did not (32 of 38 [84%] <i>v</i> 53 of 2585 [2.1%]; POR, 251 [95% CI, 96.7–754]).</p><p>Lifetime prevalence of intimate partner violence was higher among women born in Australia (POR, 2.85; 95% CI, 2.23–3.64), those with","PeriodicalId":18214,"journal":{"name":"Medical Journal of Australia","volume":"221 7","pages":"386-388"},"PeriodicalIF":6.7,"publicationDate":"2024-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.5694/mja2.52436","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142290488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recommendations from the 2024 Australian evidence-based guideline for unexplained infertility: ADAPTE process from the ESHRE evidence-based guideline on unexplained infertility","authors":"Michael F Costello, Robert J Norman, Luk Rombauts, Cynthia M Farquhar, Lisa Bedson, Marlene Kong, Clare V Boothroyd, Rebecca Kerner, Rhonda M Garad, Trudy Loos, Madeline Flanagan, Ben W Mol, Aya Mousa, Daniela Romualdi, Baris Ata, Ernesto Bosch, Samuel dos Santos-Ribeiro, Ksenija Gersak, Roy Homburg, Nathalie Le Clef, Mina Mincheva, Terhi Piltonen, Sara Somers, Sesh K Sunkara, Harold Verhoeve, Helena J Teede, For the Australian NHMRC Centre for Research Excellence in Reproductive Life UI Guideline Network and the ESHRE guideline group for unexplained infertility","doi":"10.5694/mja2.52437","DOIUrl":"10.5694/mja2.52437","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>The 2024 <i>Australian evidence-based guideline for unexplained infertility</i> provides clinicians with evidence-based recommendations for the optimal diagnostic workup for infertile couples to establish the diagnosis of unexplained infertility and optimal therapeutic approach to treat couples diagnosed with unexplained infertility in the Australian health care setting. The guideline recommendations were adapted for the Australian context from the rigorous, comprehensive European Society of Human Reproduction and Embryology (ESHRE) 2023 <i>Evidence-based guideline: unexplained infertility</i>, using the ADAPTE process and have been approved by the Australian National Health and Medical Research Council.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main recommendations</h3>\u0000 \u0000 <div>The guideline includes 40 evidence-based recommendations, 21 practice points and three research recommendations addressing:\u0000\u0000 <ul>\u0000 \u0000 <li>definition — defining infertility and frequency of intercourse, infertility and age, female and male factor infertility;</li>\u0000 \u0000 <li>diagnosis — ovulation, ovarian reserve, tubal factor, uterine factor, laparoscopy, cervical/vaginal factor, male factor, additional testing for systemic conditions; and</li>\u0000 \u0000 <li>treatment — expectant management, active treatment, mechanical-surgical procedures, alternative therapeutic approaches, quality of life.</li>\u0000 </ul>\u0000 </div>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Changes in assessment and management resulting from the guideline</h3>\u0000 \u0000 <p>This guideline refines the definition of unexplained infertility and addresses basic diagnostic procedures for infertility assessment not considered in previous guidelines on unexplained infertility. For therapeutic approaches, consideration of evidence quality, efficacy, safety and, in the Australian setting, feasibility, acceptability, cost, implementation and ultimately recommendation strength were integrated across multidisciplinary expertise and consumer perspectives in adapting recommendations to the Australian context by using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework, which had not been used in past guidelines on unexplained infertility to formulate recommendations. The Australian process also included an established data integrity check to ensure evidence could be trusted to guide practice. Practice points were added and expanded to consider the Australian setting. No evidence-based recommendations were underpinned by high qualit","PeriodicalId":18214,"journal":{"name":"Medical Journal of Australia","volume":"221 8","pages":"438-446"},"PeriodicalIF":6.7,"publicationDate":"2024-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.5694/mja2.52437","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142290491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aligning legislation with clinical practice: off-label prescribing under the microscope","authors":"Narcyz Ghinea","doi":"10.5694/mja2.52439","DOIUrl":"10.5694/mja2.52439","url":null,"abstract":"<p>In the United Kingdom, there was much controversy regarding off-label prescribing of bevacizumab for age-related macular degeneration in favour of ranibizumab due to lower cost. The British General Medical Council, which regulates the medical profession in the United Kingdom, advised doctors against off-label use of bevacizumab as doctors should not prescribe unlicensed medicines when licensed alternatives exist, but this advice was criticised for conflating laws designed to regulate drug marketing with those relating to drug prescribing.<span><sup>1, 2</sup></span> Inevitably, this guidance deterred doctors from using bevacizumab.<span><sup>3</sup></span> After years of wrangling, the UK's High Court ruled in favour of the off-label use, noting that the regulator did not have the exclusive authority to determine appropriate uses of medicines.<span><sup>4</sup></span></p><p>This episode raises important questions regarding the intersection of therapeutic goods regulation and good medical practice. Therapeutic goods regulation is directed at regulating products and drug sponsors, not clinical practice. As a result, the Therapeutic Goods Administration (TGA) recognises that off-label prescribing does not fall under their jurisdiction.<span><sup>5</sup></span> However, as prescription medicines are indispensable tools for physicians, there is inevitably some crossover. This is particularly true when non-clinical factors come into play, such as affordability.<span><sup>6-8</sup></span> Off-label prescribing of medicines provides important insights into this intersection as the medicine is approved for a specific use, but not the use for which physicians prescribe them. Surprisingly, despite its ubiquity, the legal status of off-label prescribing has never been analysed in terms of the <i>Therapeutic Goods Act 1989</i> (Cwlth) and related instruments.</p><p>In Australia, the <i>Therapeutic Goods Act 1989</i> and related instruments provide the legal framework for regulation of the movement of therapeutic goods across borders and between entities.<span><sup>9</sup></span> Under the Act, unless explicitly exempted (eg, Personal Importation or Clinical Trials schemes) or specifically permitted via an authority (eg, Special Access or Authorised Prescriber schemes), it is a criminal offence and civil contravention to import, export or supply medicines or biologicals not included in the Australian Register of Therapeutic Goods (ARTG).<span><sup>8</sup></span> The technical definition of a “therapeutic good” provided for in the Act is broad and includes how the product is represented or likely to be perceived (Box). If a good is represented or perceived to be for therapeutic use, it is a therapeutic good. A “therapeutic use” is a legal phrase with a broad meaning (Box). A medicine used for a different “therapeutic use” to the approved use could be interpreted as a different product and therefore potentially an unapproved medicine. The focus of the analysi","PeriodicalId":18214,"journal":{"name":"Medical Journal of Australia","volume":"221 8","pages":"417-419"},"PeriodicalIF":6.7,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.5694/mja2.52439","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142194140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"General practitioners’ views and experiences of postpartum contraception counselling and provision: a qualitative–descriptive study","authors":"Jenna K Perkins, Sharon James, Danielle Mazza, Jessica R Botfield","doi":"10.5694/mja2.52438","DOIUrl":"10.5694/mja2.52438","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>To explore Australian general practitioners’ views and experiences of undertaking postpartum contraception counselling and provision during the 6–8-week postnatal check.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Study design</h3>\u0000 \u0000 <p>Qualitative–descriptive study; semi-structured online interviews.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Participants, setting</h3>\u0000 \u0000 <p>General practitioners who provide postnatal care in Australian primary health care, recruited using purposive, convenience, and snowball methods, 16 June – 6 July 2023.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main outcome measures</h3>\u0000 \u0000 <p>Views and experiences of postpartum contraception counselling and provision.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Twenty-three general practitioners from six states were interviewed; the mean interview time was 30 minutes (range, 21–47 minutes), twenty-two participants were women, and twenty-one worked in metropolitan areas. All participants provide postnatal checks and had the training and facilities needed for providing contraceptive implant insertions. Twelve participants had training in intrauterine device (IUD) insertion, and twenty-one worked in practices with facilities for IUD insertions. Three themes were constructed: views and preferences regarding postnatal contraception counselling; postpartum provision of long-acting reversible contraception (LARC); and opportunities for improving postpartum contraception care in general practice. While most participants recommended LARC methods at postnatal checks, only twelve were trained to insert IUDs. Time constraints, limited access to training, limited financial support, and the lack of guidelines for postnatal checks and contraception care were seen as impeding postpartum contraception counselling. Participants highlighted the importance of access to education and training, appropriate remuneration for general practitioners, multidisciplinary collaboration among health professionals, the inclusion of practice nurses, and raising awareness among mothers of the importance of postnatal checks and postpartum contraception care.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>General practitioners are well placed to facilitate discussions about contraception with women who have recently given birth. Postpartum contraception care in general practice could be improved by better access to","PeriodicalId":18214,"journal":{"name":"Medical Journal of Australia","volume":"221 7","pages":"381-385"},"PeriodicalIF":6.7,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.5694/mja2.52438","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hepatocellular carcinoma surveillance in Australia: current and future perspectives","authors":"Naomi CA Whyler,&nbsp;Sushena Krishnaswamy,&nbsp;Michelle L Giles","doi":"10.5694/mja2.52440","DOIUrl":"10.5694/mja2.52440","url":null,"abstract":"<p><span>To the Editor:</span> We read with interest the excellent review by Hui and colleagues<span>¹</span> on hepatocellular carcinoma (HCC) surveillance in Australia. HCC is increasing in incidence in Australia, and is often diagnosed late, when curative options are limited and mortality rates are high.<span>¹</span> Surveillance is recommended in high risk individuals but uptake is suboptimal; a centralised surveillance program may provide an improved model of care delivery.<span>¹</span> However, screening programs may only be successful in those with a diagnosis of a condition that increases their risk of HCC.</p><p>Improved case-finding strategies are recommended;<span>¹</span> however, an important group not discussed in this article is pregnant people. This is a unique population who is universally tested for hepatitis B in Australia,<span>²</span> and who is often interacting with the health care system for the first time at a young age, without other comorbid conditions. In those at high risk of progression to HCC, such as women from sub-Saharan Africa aged over 20 years, antenatal diagnosis provides an opportunity for education. Linkage to specialist care during pregnancy also enables the development of an HCC surveillance plan to maximise the opportunities for early diagnosis of complications.</p><p>There is evidence to suggest that, in Australia, people who are diagnosed during pregnancy with a medical condition that is associated with long term complications, such as gestational diabetes<span>³</span> and hypertensive disorders in pregnancy,<span>⁴</span> often do not engage in recommended follow-up care in the postpartum period. Postpartum retention in care in those with hepatitis B in Australia is poorly documented, but appears similar to other antenatally diagnosed conditions, with existing data estimating that less than half engage with hepatitis B care during the first year postpartum.<span>⁵</span> In addition to the barriers to accessing surveillance outlined by Hui and colleagues,<span>¹</span> engagement in care during the postpartum period may be hampered by the need to juggle family and child care responsibilities, return to the workforce, and access to child care to allow attendance at appointments.</p><p>We recommend integrating existing antenatal screening and diagnosis into strategies to identify those at high risk who may benefit from HCC surveillance, and optimising postpartum pathways of care to support these individuals.</p><p>No relevant disclosures.</p>","PeriodicalId":18214,"journal":{"name":"Medical Journal of Australia","volume":"221 7","pages":"396"},"PeriodicalIF":6.7,"publicationDate":"2024-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.5694/mja2.52440","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementability and impact in clinical research and the role of clinical trial networks","authors":"Helena J Teede,&nbsp;Karen Best,&nbsp;Frank H Bloomfield,&nbsp;Alan Cass,&nbsp;Paul Cohen,&nbsp;Sue Crengle,&nbsp;Tiffany Harris-Brown,&nbsp;Stephen Jan,&nbsp;David W Johnson,&nbsp;Samantha Keogh,&nbsp;Anne McKenzie,&nbsp;Philippa Middleton,&nbsp;Sandra Peake,&nbsp;Hashim Periyalil,&nbsp;Paul A Scuffham,&nbsp;Angela Scheppokat,&nbsp;Greg R Sharplin,&nbsp;Steve Webb","doi":"10.5694/mja2.52444","DOIUrl":"10.5694/mja2.52444","url":null,"abstract":"&lt;p&gt;The Australian Clinical Trials Alliance (ACTA) impact and implementation reference group has published guidance on clinical trial planning, design, conduct and reporting, to optimise the impact of late-phase trials.&lt;span&gt;&lt;sup&gt;1&lt;/sup&gt;&lt;/span&gt; It is critical that clinical trials are designed, executed and reported on so that the generated evidence can be implemented and applied to improve practice, health systems and policy (defined as &lt;i&gt;implementability&lt;/i&gt;).&lt;span&gt;&lt;sup&gt;1&lt;/sup&gt;&lt;/span&gt; This is particularly important for late-phase trials as results from these trials guide stakeholder decisions on adoption or removal of candidate interventions from practice and policy. The results can also be used to guide implementation, potentially supplemented by other study types. In some cases, decisions on candidate interventions may be based on a single trial, although more commonly, they are based on the synthesis of evidence from multiple trials. If the results of positive late-phase trials are not put into effect, the community benefit, impact and return on investment are lost. Therefore, to reduce wastage and optimise value to the community, who is both the funder and beneficiary of research, we need to maximise the impact of trials. This impact includes health and economic benefits and requires trials to be designed for implementability.&lt;span&gt;&lt;sup&gt;2-4&lt;/sup&gt;&lt;/span&gt;&lt;/p&gt;&lt;p&gt;Implementability is key to trial design and delivery, independent of the results of the trial. Impact is dependent on intervention efficacy and implementability. Late-phase trials should incorporate implementability and be designed to be useful to their diverse end users (including organisations, governments, clinicians and consumers).&lt;/p&gt;&lt;p&gt;Characteristics that contribute to implementability include concepts around trials that are embedded in clinical care and are pragmatic, focused on informing clinical practice and policy and considering real-world investigators, recruitment, participants, intervention, delivery and outcomes. The PRECIS-2 framework (PRagmatic Explanatory Continuum Indicator Summary framework) indicates where a trial sits on the spectrum between the explanatory “Can this intervention work under ideal conditions?” to the pragmatic “Does this intervention work under usual conditions?”. This framework highlights the vital need to identify, involve and co-design or tailor trial design to the needs of end users.&lt;span&gt;&lt;sup&gt;5&lt;/sup&gt;&lt;/span&gt; The Consolidated Framework for Implementation Research (CFIR) and similar tools are also useful to guide design and evaluation of implementation research.&lt;span&gt;&lt;sup&gt;6, 7&lt;/sup&gt;&lt;/span&gt; In implementability, key trial design considerations include eligibility and exclusion criteria, setting, requirement for a skilled workforce or specialised equipment and extent of data collection. Similarly, trial design contributes to both embedding and implementability; with the need to recognise potential differences between strategies to promote trial effi","PeriodicalId":18214,"journal":{"name":"Medical Journal of Australia","volume":"221 8","pages":"410-413"},"PeriodicalIF":6.7,"publicationDate":"2024-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.5694/mja2.52444","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hepatocellular carcinoma surveillance in Australia: current and future perspectives","authors":"Alain Braillon","doi":"10.5694/mja2.52441","DOIUrl":"10.5694/mja2.52441","url":null,"abstract":"<p><span>To the Editor:</span> Hui and colleagues must be commended for underscoring that a program with centralisation should be a cornerstone for hepatocellular carcinoma (HCC) surveillance.<span>¹</span> Indeed, with funding for quality assurance, it allows for monitoring of uptake to guarantee effectiveness and equitability. However, their narrative review deserved robust comments.</p><p>Firstly, the prerequisite for screening is a positive benefit to harm ratio and the highlighting of a positive randomised trial of patients from China should not have masked its major flaws and that another trial was negative.<span>^{2, 3}</span> Similarly, stating that “observational studies are inherently limited, given the potential for lead-time and length-time biases to overestimate survival benefit”<span>¹</span> is a euphemism.</p><p>Further, the diagnosis of small nodules (&lt; 2 cm) in a cirrhotic liver with fibrous septa and regenerative nodules is a complex issue requiring multiple investigations and, frequently, a biopsy.</p><p>Secondly, the analysis of the poor uptake of screening is wise<span>⁴</span> but it should not have ignored that there is no consensus among national recommendations: neither for imaging techniques and the serum biomarkers, nor for their combination and frequency. Rather than including a table comparing recommendations for group surveillance among national recommendations (Box 2 in Hui et al<span>¹</span>), the authors should have included a table summarising the profusion of screening methods; having so many methods suggests that none are adequate.</p><p>Lastly, Hui and colleagues should not have ignored the warnings from the US National Cancer Institute summarising the evidence for benefits and harms of HCC screening: “Based on fair evidence, screening of persons at elevated risk does not result in a decrease in mortality from hepatocellular cancer” and “Good evidence for uncommon but serious harms”.<span>⁵</span> At least Hui and colleagues should have recalled that the Gastroenterological Society of Australia must be commended as none of its four recommendations related to surveillance of HCC are graded A1.<span>⁶</span></p><p>The recommendation for screening for HCC by some professional organisations, despite lack of evidence for a positive benefit to harm ratio on relevant clinical outcomes from randomised trials, is an exception in medicine. Exceptions in medicine rarely benefit patients.</p><p>No relevant disclosures.</p>","PeriodicalId":18214,"journal":{"name":"Medical Journal of Australia","volume":"221 7","pages":"396-397"},"PeriodicalIF":6.7,"publicationDate":"2024-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.5694/mja2.52441","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Policies on the collection, analysis, and reporting of sex and gender in Australian health and medical research: a mixed methods study","authors":"Cheryl Carcel,&nbsp;Amy Vassallo,&nbsp;Laura Hallam,&nbsp;Janani Shanthosh,&nbsp;Kelly Thompson,&nbsp;Lily Halliday,&nbsp;Jacek Anderst,&nbsp;Anthony KJ Smith,&nbsp;Briar L McKenzie,&nbsp;Christy E Newman,&nbsp;Keziah Bennett-Brook,&nbsp;Zoe Wainer,&nbsp;Mark Woodward,&nbsp;Robyn Norton,&nbsp;Louise Chappell","doi":"10.5694/mja2.52435","DOIUrl":"10.5694/mja2.52435","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To explore the policies of key organisations in Australian health and medical research on defining, collecting, analysing, and reporting data on sex and gender, and to identify barriers to and facilitators of developing and implementing such policies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Study design</h3>\u0000 \u0000 <p>Mixed methods study: online planning forum; survey of organisations in Australian health and medical research, and internet search for policies defining, collecting, analysing, and reporting data by sex and gender in health and medical research.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Setting, participants</h3>\u0000 \u0000 <p>Australia, 19 May 2021 (planning forum) to 12 December 2022 (final internet search).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Main outcome measures</h3>\u0000 \u0000 <p>Relevant webpages and documents classified as dedicated organisation-specific sex and gender policies; policies, guidelines, or statements with broader aims, but including content that met the definition of a sex and gender policy; and references to external policies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The online planning forum identified 65 relevant organisations in Australian health and medical research; twenty participated in the policy survey. Seven organisations reported at least one relevant policy, and six had plans to develop or implement such policies during the following two years. Barriers to and facilitators of policy development and implementation were identified in the areas of leadership, language and definitions, and knowledge skills and training. The internet search found that 57 of the 65 organisations had some form of sex and gender policy, including all ten peer-reviewed journals and five of ten research funders; twelve organisations, including eight peak body organisations, had published dedicated sex and gender policies on their websites.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Most of the organisations included in our study had policies regarding the integration of sex and gender in health and medical research. The implementation and evaluation of these policies is necessary to ensure that consideration of sex and gender is adequate during all stages of the research process.</p>\u0000 </section>\u0000 </div>","PeriodicalId":18214,"journal":{"name":"Medical Journal of Australia","volume":"221 7","pages":"374-380"},"PeriodicalIF":6.7,"publicationDate":"2024-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.5694/mja2.52435","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}