Research Publications and Outputs

Beyond duty: Medical “heroes” and the Covid-19 pandemic

2021-02-15T00:37:33Z

Beyond duty: Medical “heroes” and the Covid-19 pandemic Lipworth, Wendy When infectious disease outbreaks strike, health facilities acquire labels such as “war zones” and “battlefields” and healthcare professionals become “heroes” on the “front line.” But unlike soldiers, healthcare professionals often take on these dangerous roles without any prior intention or explicit expectation that their work will place them in grave personal danger. This inevitably raises questions about their role-related obligations and whether they should be free to choose not to endanger themselves. In this article, I argue that it is helpful to view this situation not only through the lens of “professional duty” but also through the lens of “role-related conflicts.” Doing so has the advantage of avoiding exceptionalism and allowing us to draw lessons not only from previous epidemics but also from a wide range of far more common role-related dilemmas in healthcare.

Conflicts of interest: opening up new territories.

2021-01-12T04:57:02Z

Conflicts of interest: opening up new territories. Wiersma, Miriam; Lipworth, Wendy; Komesaroff, Paul; Kerridge, Ian Over the last few decades, awareness of the importance of managing conflicts of interest among health-related policymaking, professional, research, and clinical institutions has greatly increased. The visibility of the issue—and the widespread use of the expression “conflict of interests”—may give the impression that the underlying concepts have been clearly defined and that there is widespread consensus about processes and practices. Sadly, this is not the case. In reality, conflicts of interests are far more complex than is commonly appreciated and, because of their importance, require ongoing detailed, rigorous analysis and debate.

Biobank networking and globalisation: perspectives and practices of Australian biobanks.

2021-01-12T04:56:02Z

Biobank networking and globalisation: perspectives and practices of Australian biobanks. Light, Edwina; Wiersma, Miriam; Dive, Lisa; Kerridge, Ian; Lipworth, Wendy; Stewart, Cameron; Kowal, Emma; Marlton, Paula; Critchley, Christine Objective This study examined the practices and attitudes of Australian biobanks regarding access to samples and data, as well as local and global networking with other biobanks. Methods This was a mixed-methods study, including an online survey of Australian biobank administrators and qualitative interviews with survey participants. The survey examined the criteria applied when considering requests to share or network. The interviews explored attitudes and practices regarding sharing and networking. Results Most (90.9%; 30/33) biobanks offered access to their samples and data to others, principally for research (90.6%; 29/32). The most common criteria used to evaluate access requests included ethical oversight (84.8%; 28/33), scientific merit (84.8%; 28/33) and intended use (81.8%; 27/33). Just over two-thirds (69.7%; 23/33) of biobanks participated in Australian networks, and 39.1% (9/23) participated in global networks. Networking took the form of both sharing standardised operating procedures and policies (60.9%) and sharing samples and data (43.5%). Thirteen of the 16 interviewees participated in networks. Motivations for sharing included scientific necessity, sharing expertise and standardising operations and governance. Significant barriers to networking remain, including insufficient resources, inconsistent regulations and procedures, and cultural and political issues to do with the conduct of research. Conclusions Many Australian biobanks are already active participants in various types of global biobanking. If biobanks are to expand and make the most of their involvement in global networks, then important barriers need to be overcome.

Public trust and global biobank networks

2021-01-12T04:55:13Z

Public trust and global biobank networks Dive, Lisa; Critchley, Christine; Otlowski, Margaret; Mason, Paul; Wiersma, Miriam; Light, Edwina; Stewart, Cameron; Kerridge, Ian; Lipworth, Wendy Biobanks provide an important foundation for genomic and personalised medicine. In order to enhance their scientific power and scope, they are increasingly becoming part of national or international networks. Public trust is essential in fostering public engagement, encouraging donation to, and facilitating public funding for biobanks. Globalisation and networking of biobanking may challenge this trust. We report the results of an Australian study examining public attitudes to the networking and globalisation of biobanks. The study used quantitative and qualitative methods in conjunction with bioethical analysis in order to determine factors that may contribute to, and threaten, trust. Our results indicate a generally high level of trust in biobanks and in medical research more broadly. Key factors that can reduce perceived trustworthiness of biobanks are commercialisation and involvement in global networking. We conclude that robust ethical oversight and governance standards can both promote trust in global biobanking and ensure that this trust is warranted.

Promoting ethics across the healthcare sector: what can codes achieve?

2021-01-12T03:22:46Z

Promoting ethics across the healthcare sector: what can codes achieve? Lipworth, Wendy; Kerridge, Ian; Montgomery, Kathleen; Komesaroff, Paul A. Over the course of the twentieth century, numerous national and international ethics “codes” have been developed. While such codes serve important substantive and symbolic functions, they can also pose challenges. In this article, we discuss these challenges, noting that they fall into four main categories relating to conceptual tensions, power imbalances, organisational barriers, and threats of exploitation. We illustrate these challenges using examples provided from the UNESCO Universal Declaration on Bioethics and Human Rights (UDBHR). We emphasise the importance of accountability in the development and maintenance of national and international codes and argue that, despite all their challenges, codes provide an important common language among otherwise disparate and sometimes adversarial groups, and provide visible and explicit sets of standards that may be invoked by community members to criticise and hold powerful bodies to account. This is particularly important for practitioners and researchers who belong to organisations that are signatories to codes, who can use these codes to both guide and justify ethical behaviour in the face of competing organisational, professional and political imperatives.

Women in contact with the Sydney LGBTIQ communities: Report of the SWASH Lesbian, Bisexual and Queer Women’s Health Survey 2016, 2018, 2020

2021-01-08T02:48:38Z

Women in contact with the Sydney LGBTIQ communities: Report of the SWASH Lesbian, Bisexual and Queer Women’s Health Survey 2016, 2018, 2020 Mooney-Somers, Julie; Deacon, Rachel; Anderst, Ania; Rybak, Luna; Akbany, Afreen; Philios, Luka; Keeffe, Sophie; Price, Karen; Parkhill, Nicolas A lack of systematic, nuanced research on the health and wellbeing of Australian lesbian, bisexual and queer (LBQ) women (cis and trans) has been a significant barrier to understanding, recognising and addressing their health needs. A range of social, psychological and economic factors mean that this group has poorer health outcomes than their heterosexual peers. Stigma, family and community rejection, and discrimination towards LBQ women can impact on health and wellbeing, the delivery of health services, and their access to services. The inclusion of lesbian and bisexual women in the 2018 National Women’s Health Strategy1 and the 2018 NSW Women’s Strategy2 is recognition that while LBQ women share many health challenges with heterosexual women, some health problems may be more prevalent, risk factors may be different, and interventions may need to be tailored to the needs of this group. In NSW, the development of an LGBTI Health Strategy (due to be released in 2021) is an acknowledgment that health care systems need to consider how they provide health care to these populations to ensure equity of access and outcomes. The SWASH survey is a comprehensive survey of important health issues relevant to lesbian, bisexual, queer and other non-heterosexual identifying women engaged with Sydney’s lesbian, gay, bisexual, transgender, intersex and queer (LGBTIQ) communities. SWASH has been run by researchers in collaboration with ACON every two years since 1996, and since 2009 has been run by researchers at the University of Sydney. The survey is regularly revised to reflect the needs of LGBTIQ communities and knowledge deficits identified through research literature. Where possible, questions are sourced from established national surveys. Australian epidemiological data on the health and wellbeing of LBQ women remains limited. Sexuality and gender indicators are seldom included in large epidemiological surveys. Even when they are, data is often reported only by sexuality (e.g. LGB people vs heterosexual people) and not by sexuality and gender (e.g. LBQ women, GBQ men, heterosexual women, heterosexual men). SWASH provides a much-needed local evidence base to inform policy and best practice in healthcare and prevention for chronic diseases, mental health and wellbeing, sexual and reproductive health, and ageing. This report presents results from the three most recent iterations of the survey conducted at the Mardi Gras Fair Day and other community events and venues during the Sydney Gay and Lesbian Mardi Gras seasons in 2016, 2018 and 2020. In 2020, 1588 lesbian, bisexual, queer and other non-heterosexually identifying women (cis and trans) and non-binary people returned valid surveys; an unprecedented number in the 24-year history of the SWASH survey. This data provides unparalleled insights into the health of lesbian, bisexual, queer and other non-heterosexual identifying women aged 16 to 71 years who engaged with LGBTIQ communities in and around Sydney (where 85% of respondents reside). Our analyses highlight several areas of particular concern – many of which have persisted over time – where mainstream preventive health interventions that are inclusive of, or targeted to, LBQ women are needed.

Obligations and preferences in knowing and not knowing: the importance of context

2020-10-19T00:03:12Z

Obligations and preferences in knowing and not knowing: the importance of context Dive, Lisa; Newson, A.J. Commentary on Davies: "The right not to know and the obligation to know"

Ethical issues in reproductive genetic carrier screening

2020-10-19T00:02:29Z

Ethical issues in reproductive genetic carrier screening Dive, Lisa; Newson, A.J. Reproductive Carrier Screening (RCS) involves testing individuals or couples to determine their likelihood of having a child with certain inherited genetic conditions. RCS raises ethical considerations, including: the acceptable goals of screening, how to choose the genes to test for, ensuring recipients make choices consistent with their preferences, reporting results, funding models, and ensuring that RCS programs reflect community values. The Australian Reproductive Genetic Carrier Screening Project (ARGCSP; ‘Mackenzie’s Mission’) is a research project investigating how RCS could be provided nationally in future. In this paper we outline the ethical issues in RCS as relevant to initiatives like the ARGCSP.

The direct-to-consumer market for stem cell-based interventions in Australia: Exploring the experiences of patients Special Report

2020-07-09T02:29:25Z

The direct-to-consumer market for stem cell-based interventions in Australia: Exploring the experiences of patients Special Report Waldby, C; Hendl, T; Kerridge, I; Lipworth, W; Lysaght, T; Munsie, M; Stewart, C The prevalence of businesses selling autologous stem cell-based interventions (ASCBI) to patients in Australia has raised serious concerns about how weaknesses in regulation have enabled the emergence of an industry that engages in aggressive marketing of unproven treatments to patients. Little is known about how patients experience this marketing and their subsequent interactions with practitioners. This paper reports results from fifteen semi-structured interviews with patients and carers, and also draws upon discussion conducted with patients, carers and family members (22 participants) in a workshop setting. We explore how Australian patients and carers understand and experience these interventions, and how their presumptions about the ethics of medical practice, and the regulatory environment in Australia have conditioned their preparedness to undergo unproven treatments

Health Professionals “Make Their Choice”: Pharmaceutical Industry Leaders’ Understandings of Conflict of Interest

2020-07-09T02:37:49Z

Health Professionals “Make Their Choice”: Pharmaceutical Industry Leaders’ Understandings of Conflict of Interest Grundy, Q; Tierney, L; Mayes, C; Lipworth, W Conflicts of interest, stemming from relationships between health professionals and the pharmaceutical industry, remain a highly divisive and inflammatory issue in healthcare. Given that most jurisdictions rely on industry to self-regulate with respect to its interactions with health professionals, it is surprising that little research has explored industry leaders’ understandings of conflicts of interest. Drawing from in-depth interviews with ten pharmaceutical industry leaders based in Australia, we explore the normalized and structural management of conflicts of interest within pharmaceutical companies. We contrast this with participants’ unanimous belief that the antidote to conflicts of interest with health professionals were “informed consumers.” It is, thus, unlikely that a self-regulatory approach will be successful in ensuring ethical interactions with health professionals. However, the pharmaceutical industry’s routine and accepted practices for disclosing and managing employees’ conflicts of interest could, paradoxically, serve as an excellent model for healthcare.

Unconventional Practice, “Innovative” Interventions and the National Law

2020-07-09T02:45:28Z

Unconventional Practice, “Innovative” Interventions and the National Law Stewart, C; Kerridge, I; Waldby, C; Lipworth, W; Munsie, M; Lysaght, T; Rudge, C; Ghinea, N; Eckstein, L; Neilsen, J; Kaldor, J; Nicol, D This column explores a recent health profession disciplinary case which throws light on the problems of unconventional interventions by medical practitioners under the Health Practitioner Regulation National Law Act 2009 (Qld). The case involved “innovative” practices which were later found to have been scientifically unsupported, dangerous to patients and grounds for cancelling the health practitioner’s registration. The article looks at common features of these kinds of cases in Australia and then examines recent attempts by the Medical Board of Australia to draft policy guidance around the use of unconventional practice in medicine. The article concludes with a number of changes to improve the effectiveness of the proposed policy.

Are my religious beliefs anyone’s business? A framework for declarations in health and biomedicine

2020-07-09T02:46:39Z

Are my religious beliefs anyone’s business? A framework for declarations in health and biomedicine Ghinea, N; Wiersma, M; Kerridge, I; Lipworth, W Conflicts of interests (COIs) are typically divided into those that are financial and those that not. While there is general agreement that financial COIs have a significant impact on decisions and need to be declared and managed, the status of non-financial COIs continues to be disputed. In a recent BMJ feature article it was proposed that religious beliefs should be routinely declared as an interest. The article generated over 41 responses from the medical community and health researchers, which put forward diverse and opposing views. In this paper we analyse the discourse to shed further light on the reasons put forward for and against declaring religious beliefs. We argue for a middle path in which only material beliefs should be declared, and then only when there are no extenuating circumstances. To this end, we present a framework to help evaluate the materiality of interests that can be used for both financial and non-financial interests.

Transvaginal mesh, gender, and the ethics of clinical innovation

2020-07-09T02:32:10Z

Transvaginal mesh, gender, and the ethics of clinical innovation Wiersma, M; Kerridge, I; Lipworth, W On the 10th of October 2018, Australian Health Minister Greg Hunt issued a national apology to the Australian women who experienced “horrific outcomes” following surgery using transvaginal mesh—acknowledging the “historic agony and pain that has come from mesh implantation”. This apology followed many decades of “innovative” use of transvaginal mesh for the treatment of pelvic organ prolapse. We use the case of transvaginal mesh to explore how clinical innovation may not only harm patients, but also entrench vulnerability and exacerbate existing inequities—in this case, those relating to gender.

Against the use and publication of contemporary unethical research: the case of Chinese transplant research

2020-07-09T02:47:51Z

Against the use and publication of contemporary unethical research: the case of Chinese transplant research Higgins, W; Rogers, W; Ballantyne, A; Lipworth, W Recent calls for retraction of a large body of Chinese transplant research and of Dr. Jiankui He’ gene editing research has led to renewed interest in the question of publication, retraction and use of unethical biomedical research. In Part 1 of this paper, we briefly review the now well-established consequentialist and deontological arguments for and against the use of unethical research. We argue that, while there are potentially compelling justifications for use under some circumstances, these justifications fail when unethical practices are ongoing—as in the case of research involving transplantations in which organs have been procured unethically from executed prisoners. Use of such research not only displays a lack of respect and concern for the victims but also undermines efforts to deter unethical practices. Such use also creates moral taint and renders those who use the research complicit in continuing harm. In Part 2, we distinguish three dimensions of “non-use” of unethical research: non-use of published unethical research, non-publication, and retraction and argue that all three types of non-use should be upheld in the case of Chinese transplant research. Publishers have responsibilities to not publish contemporary unethical biomedical research, and where this has occurred, to retract publications. Failure to retract the papers implicitly condones the research, while uptake of the research through citations rewards researchers and ongoing circulation of the data in the literature facilitates subsequent use by researchers, policymakers and clinicians.

A major new alliance in Australian healthcare: the Australian consensus framework for ethical collaboration in the healthcare sector

2020-07-09T02:36:33Z

A major new alliance in Australian healthcare: the Australian consensus framework for ethical collaboration in the healthcare sector Lipworth, W; Fitzpatrick, J; Cosenza, A; Kerridge, I; Subramanian, P; Verhoeven, A; Wells, L The “Australian Consensus Framework for Ethical Collaboration in the Healthcare Sector” (ACF) is an Australian initiative aimed at countering dysfunction and growing mistrust in the health sector through the development of a cross-sectoral consensus framework. The development of this framework arose from Australia’s involvement in the Asia Pacific Economic Cooperative (APEC) and has since become the largest of its kind internationally, with over 70 signatories representing professional bodies, industry organisations, hospital and health services associations, regulators, and patient and advocacy groups. In this article, we describe and critique the framework and outline its implementation.

Does consumer engagement in health technology assessment enhance or undermine equity?

2020-07-09T02:34:33Z

Does consumer engagement in health technology assessment enhance or undermine equity? Ghinea, N; Lipworth, W; Kerridge, I Consumer engagement in decisions about the funding of medicines is often framed as a good in and of itself, and as an activity that should be universally encouraged. A common justification for calls for consumer engagement is that it enhances equity. In this paper we systematically critique this assumption. We show that consumer engagement may undermine equity as well as enhance it, and show that a simple relationship cannot be assumed but must be justified and demonstrated. In concluding we present a number of challenges that need to be overcome in order for consumer engagement to contribute to health technology assessment in a morally and politically sound manner.

Beyond flourishing: Intersecting uses and interests in the neurotechnology marketplace

2020-07-07T23:56:49Z

Beyond flourishing: Intersecting uses and interests in the neurotechnology marketplace Forlini, C; Lipworth, W; Carter, A; Kerridge, I

Formulating an Ethics of Pharmaceutical Disinvestment

2020-04-14T05:40:37Z

Formulating an Ethics of Pharmaceutical Disinvestment Pace, J; Laba, T; Nisingizwe, M; Lipworth, W There is growing interest among pharmaceutical policymakers in how to “disinvest” from subsidised medicines. This is due to both the rapidly rising costs of healthcare and the increasing use of accelerated and conditional reimbursement pathways which mean that medicines are being subsidised on the basis of less robust evidence of safety and efficacy. It is crucial that disinvestment decisions are morally sound and socially legitimate, but there is currently no framework to facilitate this. We therefore reviewed the bioethics literature in order to identify ethical principles and concepts that might be relevant to pharmaceutical disinvestment decisions. This revealed a number of key ethical considerations—both procedural and substantive—that need to be considered when making pharmaceutical disinvestment decisions. These principles do not, however, provide practical guidance so we present a framework outlining how they might be applied to different types of disinvestment decisions. We also argue that, in this context, even the most rigorous ethical reasoning is likely to be overridden by moral intuitions and psychological biases and that disinvestment decisions will need to strike the right balance between respecting justifiable moral intuitions and overriding unjustifiable psychological impulses.

“Some sort of fantasy land”: a qualitative investigation of appropriate prescribing in oncology.

2020-04-14T06:54:36Z

“Some sort of fantasy land”: a qualitative investigation of appropriate prescribing in oncology. Ghinea, N; Wiersma, M; Kerridge, I; Olver, I; Pearson, S; Day, R; Liauw, W; Lipworth, W Increasing the appropriateness of prescribing has long been a focus of government, non-government and professional organisations. Progress towards this is made difficult by the fact appropriate prescribing remains inconsistently defined and is the subject of ongoing intense disagreement. In this study we attempted to understand why this is the case in oncology through the qualitative analysis of semi-structured interviews with 16 Australian oncologists and haematologists. We found that oncologists framed appropriate prescribing in terms of the following inter-related, and at times opposed, values: civic mindedness; hope and compassion; realism; and virtue in motivation. These values cannot be ranked a priori, and therefore what is meant by appropriate prescribing depends upon both the strength of arguments used to justify particular definitions, and the values and goals of affected communities.

Status, respect and stigma: a qualitative study of non-financial interests in medicine

2020-04-14T06:57:08Z

Status, respect and stigma: a qualitative study of non-financial interests in medicine Wiersma, M; Kerridge, I; Lipworth, W Conflicts of interest (COI) in health and medicine have been the source of considerable public and professional debate. Much of this debate has focused on financial, rather than non-financial COI, which is a significant lacuna because non-financial COI can be just as influential as financial COI. In an effort to explore the nature and effects of non-financial, as well as financial COI, we conducted semi-structured interviews with 11 Australian medical professionals regarding their experiences of, and attitudes towards, COI. We found that this group of medical professionals saw non-financial interests—most notably the pursuit of status and respect, and the avoidance of stigma—as potentially conflicting with other important interests (such as patient care).

Disruption, Diversity, and Global Biobanking

2020-01-21T22:18:24Z

Disruption, Diversity, and Global Biobanking Light, E; Wiersma, M; Dive, Lisa; Kerridge, I; Critchley, C; Lipworth, W Beskow and Weinfurt’s analysis of biobank consent comprehension draws attention to important epistemic and axiological questions, not the least of which concern how we can know what are the right or wrong ways to conduct contemporary biobank research. Their empirical work highlights uncertainty and dissonance among stakeholders about what immutable values should underpin biobank consent practices, as well as the differences between what experts can expect to occur and what will happen when consent and other agreed processes are put into action. These questions become potentially more complex as biobanks continue to network globally, and the moral, social, legal and political connections among and between prospective participants, researchers and regulators are disrupted. The initial findings of our Australian research of the global networking of biobanks (in progress) suggest that factors other than models of consent can be as, or more, important to people’s trust and engagement with global biobanking. Similar to Beskow and Weinfurt’s study, these perspectives exhort us to ensure that current efforts toward global harmonization of biobanking regulatory frameworks are informed by diverse perspectives garnered from both theoretical and empirical methods.

Guidelines for ethical relationships between health professionals and industry

2020-01-14T23:47:56Z

Guidelines for ethical relationships between health professionals and industry Komesaroff, P; Kerridge, I; Lipworth, W; Jureidini, J; Loblay, R; Gruen, R; Harvey, K; Malpas, P; Stewart, C; Kilham, H; Clarke, C; Carney, S; Rogers, W; Greenberg, P

Social and Ethical Implications of Precision Medicine

2020-01-13T21:33:28Z

Social and Ethical Implications of Precision Medicine Lipworth, W; Kerridge, I; Nicol, D; Otlowski, M

An Ethical Framework for Funding Rare Disease Therapies

2020-01-13T22:14:42Z

An Ethical Framework for Funding Rare Disease Therapies Lipworth, W

Medical Ethics

2020-01-13T22:06:36Z

Medical Ethics Lipworth, W; Strong, K; Kerridge, I Broadly speaking, ethics is concerned with the wellbeing of individuals and societies and asks questions about what we ought to do. “Practical ethics” or “applied ethics” considers this in specific contexts, such as medicine, government, law enforcement and business. “Bioethics” is one type of practical ethics. Bioethics refers to the ethics of the biological sciences and includes medical ethics, nursing ethics, pharmacy/pharmaceutical ethics, research ethics, psychological ethics, public health ethics and research ethics. Broad conceptions of bioethics also include environmental ethics and the ethics of veterinary practice. This chapter focuses on the key issues that emerge in the context of clinical medical practice (“medical ethics”) and on the frameworks that one might use to resolve these issues.

Is it ethical to prescribe paracetamol for acute low back pain and osteoarthritis?

2020-01-13T03:30:57Z

Is it ethical to prescribe paracetamol for acute low back pain and osteoarthritis? Day, RO; Cohen, M; Coleshill, MJ; Ghinea, N; Lipworth, W; Maher, CG; Latimer, J; Lin, CWC; McLachlan, AJ Despite accumulating evidence indicating that paracetamol is no more efficacious than placebo for acute uncomplicated low back pain and symptomatic osteoarthritis, it is still prescribed for these conditions. This is likely due to perceived clinical improvement in pain observed when the medicine is taken and the known harms associated with pharmacological alternatives. The benefits observed in the majority of patients are, however, likely to be placebo effects. This scenario poses an ethical dilemma between respecting patient autonomy by providing complete information while also promoting clinical benefit (beneficence). This article discusses this situation and considers a framework in which paracetamol might continue to be prescribed for these conditions in an ethical manner, namely through discussing the evidence and the benefit that some patients experience from it.

Applying the Theoretical Domains Framework to identify barriers and targeted interventions to enhance nurses’ use of electronic medication management systems in two Australian hospitals

2020-01-13T04:07:03Z

Applying the Theoretical Domains Framework to identify barriers and targeted interventions to enhance nurses’ use of electronic medication management systems in two Australian hospitals Debono, D; Taylor, N; Lipworth, W; Greenfield, D; Travaglia, J; Black, D; Braithwaite, J Background Medication errors harm hospitalised patients and increase health care costs. Electronic Medication Management Systems (EMMS) have been shown to reduce medication errors. However, nurses do not always use EMMS as intended, largely because implementation of such patient safety strategies requires clinicians to change their existing practices, routines and behaviour. This study uses the Theoretical Domains Framework (TDF) to identify barriers and targeted interventions to enhance nurses’ appropriate use of EMMS in two Australian hospitals. Methods This qualitative study draws on in-depth interviews with 19 acute care nurses who used EMMS. A convenience sampling approach was used. Nurses working on the study units (N = 6) in two hospitals were invited to participate if available during the data collection period. Interviews inductively explored nurses’ experiences of using EMMS (step 1). Data were analysed using the TDF to identify theory-derived barriers to nurses’ appropriate use of EMMS (step 2). Relevant behaviour change techniques (BCTs) were identified to overcome key barriers to using EMMS (step 3) followed by the identification of potential literature-informed targeted intervention strategies to operationalise the identified BCTs (step 4). Results Barriers to nurses’ use of EMMS in acute care were represented by nine domains of the TDF. Two closely linked domains emerged as major barriers to EMMS use: Environmental Context and Resources (availability and properties of computers on wheels (COWs); technology characteristics; specific contexts; competing demands and time pressure) and Social/Professional Role and Identity (conflict between using EMMS appropriately and executing behaviours critical to nurses’ professional role and identity). The study identified three potential BCTs to address the Environmental Context and Resources domain barrier: adding objects to the environment; restructuring the physical environment; and prompts and cues. Seven BCTs to address Social/Professional Role and Identity were identified: social process of encouragement; pressure or support; information about others’ approval; incompatible beliefs; identification of self as role model; framing/reframing; social comparison; and demonstration of behaviour. It proposes several targeted interventions to deliver these BCTs. Conclusions The TDF provides a useful approach to identify barriers to nurses’ prescribed use of EMMS, and can inform the design of targeted theory-based interventions to improve EMMS implementation.

Real-world Data to Generate Evidence About Healthcare Interventions

2019-10-24T01:09:47Z

Real-world Data to Generate Evidence About Healthcare Interventions Lipworth, W

An Ethics Framework for Big Data in Health and Research

2019-10-24T01:11:57Z

An Ethics Framework for Big Data in Health and Research Xafis, V; Schaefer, GO; Labude, MK; Brassington, I; Ballantyne, A; Lim, HY; Lipworth, W; Lysaght, T; Stewart, C; Sun, S; Laurie, GT; Tai, ES

Hitting the white ceiling: Structural racism and Aboriginal and Torres Strait Islander university graduates

2019-07-22T14:07:13Z

Hitting the white ceiling: Structural racism and Aboriginal and Torres Strait Islander university graduates Plater, S; Mooney-Somers, Julie; Barclay, Lesley; Boulton, John This article reports on a study that explored what it means to be a mature-age Aboriginal and Torres Strait Islander university graduate in the context of age, life-stage, history, culture, socioeconomic status, race and place. Using narrative interview data and fieldwork observation, we focus on the graduates’ workplace experiences and take a case study approach to amplify their voices. We argue that the data challenges the ideological construct of Australia as a ‘post-racial’ society and illustrates how interrelated variants of structural racism function to sanction, silence and control educated Aboriginal and Torres Strait Islander people, divide communities into quasi-hierarchies and sustain white power and privilege. We show how these variants are expressed as low expectations, shadeism, culturism and privilege protectionism, and argue that their enactment can erect an invisible barrier to Aboriginal and Torres Strait Islander professional progression: a ‘white ceiling’ above which many graduates struggle to ascend.

Conflicts of interest: new thinking, new processes

2019-08-22T07:43:42Z

Conflicts of interest: new thinking, new processes Komesaroff, P; Kerridge, I; Lipworth, W

Mistreatment in Australian medical education: a student-led scoping of experiences

2019-08-23T06:22:43Z

Mistreatment in Australian medical education: a student-led scoping of experiences Szubert, A.-K; Gibberd, A.; Buisson, E.; Hooker, C; Ivory, K. Background: Evidence of bullying and harassment of medical students and junior doctors has existed for over 30 years. However, there has been little attempt to explore the dimensions of this issue in Australia to date. Given the evidence which indicates that experiencing abusive behaviour has a detrimental effect on professional identity formation and on mental health, the Australian Medical Students’ Association (AMSA) undertook a national scoping study to better understand the experiences of Australian medical students. Methods: We conducted a mixed methods survey of the 16,959 students enrolled in a medical degree at an Australian university in 2015. An anonymous, voluntary online questionnaire was distributed through AMSA’s social media, email newsletter and website, and medical students’ societies. Results: We received 519 responses, including 194 (37%) detailing at least one incident of bullying or harassment. 335 (65%) survey respondents were women and 345 (67%) were in the clinical years of their training. 60% of all respondents reported experiencing or witnessing mistreatment during their medical education. The most common theme in the free text was belittlement of the student’s competence and capacity to be a good doctor. Some gave details about how universities failed to prevent or appropriately respond to students’ experiences of bullying and harassment. Conclusion: In line with international data, this study shows that many Australian medical students perceive mistreatment as an important problem that is not always managed well by faculties. Multi-pronged policy and practice responses are needed to instigate cultural change in Australian medical education.

Enhancing use of emergency contraceptive pills: A systematic review of women’s attitudes, beliefs, knowledge and experiences in Australia

2019-10-10T09:36:19Z

Enhancing use of emergency contraceptive pills: A systematic review of women’s attitudes, beliefs, knowledge and experiences in Australia Mooney-Somers, Julie; Amber, Lau; Bateson, Deborah; Richters, Juliet; Stewart, Mary; Black, Kirsten; Nothnagle, Melissa Over a decade after emergency contraceptive pills (ECPs) became available without a prescription, the rate of unintended pregnancies remains high in many settings. Understanding women’s experiences and perceptions of ECPs may provide insights into this underutilisation. We systematically searched databases to identify qualitative and quantitative primary studies about women’s beliefs, knowledge and experiences of ECPs in Australia. Findings demonstrate persistent misunderstandings around access, how ECPs work, and a moral discourse around acceptable versus unacceptable use. Addressing knowledge and the stigma around ECPs use is fundamental to increasing the use of this medically safe and effective strategy.

“I see it everywhere...” young people’s exposure to sexual content in social media: a qualitative study of Australian adolescents’ social media use

2019-08-22T07:58:26Z

“I see it everywhere...” young people’s exposure to sexual content in social media: a qualitative study of Australian adolescents’ social media use Lewis, Larissa; Mooney-Somers, Julie; Guy, Rebecca; Watchirs-Smith, Lucy; Skinner, S. Rachel Background: Surveys suggest over 40% of young people 13-16 years have seen some form of sexual content online in the past 12 months. There is little research exploring the pathways through which exposure occurs or descriptions of such content. While there is much public concern regarding exposure to sexual content, Australian students receive little or no education on mitigating the impact of sexual content online. Methods: We conducted focus groups with high school students in an aim to discover young people’s experience of exposure to sexual content in social media. In this paper we describe these pathways to sexual content exposure, the nature of the sexual content young people are exposed to and their views about this exposure. Results: Focus groups found that exposure to sexual content through social media occurred through networks of ‘friends’ or followers, or paid-for advertising. Content ranged from subtle messages/photos to explicit pornographic pictures/videos. Young people described much of their exposure was unwanted. Conclusions: Exposure to sexual content, no matter the scope and intensity, is almost unavoidable among young people who use social media. Utilising this information to educate young people on mitigating the impact of sexual content, rather than trying to prevent young people from viewing it, could be a more effective approach.

Changes in social networks are associated with lesbian, bisexual and queer women quitting smoking: an analysis of Australian survey data

2019-08-22T07:43:30Z

Changes in social networks are associated with lesbian, bisexual and queer women quitting smoking: an analysis of Australian survey data Kolstee, Johann; Deacon, Rachel M; Haidar, Samar; Gray, James; Mooney-Somers, Julie Introduction & Aims: Lesbian, bisexual and queer (LBQ) women in Australia and internationally are smoking at least twice the rate of women in the general population. An understanding of smoking behaviours in this population is essential in order to develop effective interventions. Our analysis aimed to investigate differences in smoking patterns and contexts of smoking between current smokers and recent quitters (<2 years to 1 month). Design & Methods: Data were collected through an online anonymous survey conducted in mid-2015. Participants were recruited online from a variety of social networking sites and community based mailing groups. Results: Overall 257 LBQ women completed the survey, 73% current smokers and 27% recent quitters; nearly all had smoked daily at some point in their lives. Multivariate analysis showed recent quitters were less likely to have some (aOR 0.19, 95% CI 0.05-0.71) or half/most/all (aOR 0.12, 95% CI 0.03-0.048) close friends who smoked compared to none, and were more likely to have a non-smoking (aOR 10.2, 95% CI 3.86-27.0) or no regular partner (aOR 4.01, 95% CI 1.47-10.9) than one who smoked. Non-Anglo-Australian women were also more likely to be recent quitters (aOR 2.45 (95% CI 1.10-5.42)) than Anglo-Australian women. Discussion & Conclusions: Understanding the social significance of partners and friends in LBQ women’s smoking and cessation efforts will be important for developing meaningful, effective and targeted interventions to address the persistent high rates of smoking in this population.

Women in contact with the Northern Rivers and Mid North Coast LGBTQ communities: Report of the SWASH Lesbian, Bisexual and Queer Women’s Health Survey 2018

2019-08-23T06:29:11Z

Women in contact with the Northern Rivers and Mid North Coast LGBTQ communities: Report of the SWASH Lesbian, Bisexual and Queer Women’s Health Survey 2018 Mooney-Somers, Julie; Deacon, Rachel M; Price, Karen; Parkhill, Nicolas A lack of systematic, nuanced research on the health and wellbeing of Australian lesbian, bisexual and queer (LBQ) women has been a significant barrier to understanding, recognising and addressing their health needs. At worst, LBQ women’s health needs have been largely ignored. At best, they have been considered to be synonymous with general women’s health. While sex between women is considered relatively low risk to health, a range of social, psychological and economic factors mean that this minority group has poorer health outcomes than their heterosexual peers. Stigma, family and community rejection and discrimination can impact on health and wellbeing, the delivery of health services, and women’s access to services. The SWASH survey is a comprehensive survey of important health issues relevant to LBQ and other non-heterosexual identifying women engaged with Sydney’s lesbian, gay, bisexual, transgender and queer (LGBTQ) communities. The survey covers sexual health and wellbeing, violence, mental health, tobacco use, illicit drug use, alcohol consumption, and cancer screening behaviours. SWASH has run every two years since 1996, and since 2009 has been run by researchers at the University of Sydney in collaboration with ACON. The survey is regularly revised to reflect the needs of LGBTQ communities and knowledge deficits identified through research literature. Where possible, questions are sourced from established national surveys such as the Australian Health Survey (AHS), National Drug Strategy Household Survey (NDSHS), Australian Study of Health and Relationships (ASHR), and Australian Longitudinal Survey of Women’s Health (ALSWH). SWASH provides a much needed local evidence base to inform best practice in healthcare and prevention for chronic diseases, mental health and wellbeing, sexual and reproductive health and ageing. Full background on the SWASH project and the results from the 2018 survey can be found in the main SWASH report. For the 2018 iteration of SWASH, we undertook sustained community engagement in the Northern Rivers and Mid North Coast region of NSW to generate sufficient numbers for a regional analysis. The SWASH NR-MNC report presents results based on surveys where participants who resided in this region.

Women in contact with the Sydney LGBTQ communities: Report of the SWASH Lesbian, Bisexual and Queer Women's Survey 2014, 2016, 2018

2020-01-28T04:26:21Z

Women in contact with the Sydney LGBTQ communities: Report of the SWASH Lesbian, Bisexual and Queer Women's Survey 2014, 2016, 2018 Mooney-Somers, Julie; Deacon, Rachel M; Scott, Polly; Price, Karen; Parkhill, Nicolas The SWASH survey is a comprehensive survey of important health issues relevant to lesbian, bisexual, queer (LBQ) and other non-heterosexual identifying women engaged with Sydney's lesbian, gay, bisexual, transgender and queer (LGBTQ) communities. The survey covers sexual health and wellbeing, violence, mental health, tobacco use, illicit drug use, alcohol consumption, and cancer, STI and HIV screening. SWASH has run every two years since 1996, and since 2009 has been run by researchers at the University of Sydney in collaboration with ACON. The survey is regularly revised to reflect the needs of LGBTQ communities and knowledge deficits identified through research literature. Where possible, questions ore sourced from established notional surveys such as Australian Health Survey, National Drug Strategy Household Survey, Australian Study of Health and Relationships, and Australian Longitudinal Survey of Women Health. Australian epidemiological data on the health and wellbeing of LBQ women remains inconsistent. The inclusion of sexuality indicators in large epidemiological surveys remains patchy, and data is often reported only by sexuality (e.g. LGB people vs heterosexual people) and not by sexuality and gender (e.g. LBO women, GBQ men, heterosexual women, heterosexual women). In this context, SWASH provides a unique and important source of health-related information on Australian LBQ women and now, non-binary people. This report presents results from the three most recent iterations of the survey conducted at the Mardi Gras Fair Day and other community events and venues during the Sydney Gay and Lesbian Mardi Gras seasons in 2014, 2016 and 2018. The report highlights several areas of particular concern (some of which have persisted over time), such as the need for mainstream preventative health interventions that ore inclusive of or targeted to this group.

Making sense of professional conflicts and quandaries

2020-01-12T21:40:53Z

Making sense of professional conflicts and quandaries Lipworth, W; Montgomery, K

Limiting religious contributions – a response to Schuklenk

2019-10-10T09:36:23Z

Limiting religious contributions – a response to Schuklenk Wiersma, M; Ghinea, N; Lipworth, W

The persistence of professional boundaries in health care: A re-examination using a theory of foundational values

2019-08-23T06:23:08Z

The persistence of professional boundaries in health care: A re-examination using a theory of foundational values Montgomery, K; Lipworth, W; Fitzgerald, L

Clarifying the relationship between serious ethical violations and conflicts of interest

2019-10-10T09:36:18Z

Clarifying the relationship between serious ethical violations and conflicts of interest Lipworth, W; Ghinea, N; Kerridge, I

Consent in the face of death

2019-10-10T09:36:20Z

Consent in the face of death Scanlan, Camilla Louise; Stewart, C; Kerridge, I While the traditional model of consent is supported by codes and theories of ethics, is enshrined in law, and provides the core of health policy and clinical governance, it is unclear how accurately it reflects clinical practice and in particular how accurately it accounts for edition-making in 'high-risk' situations where patients are critically ill and facing death.

“Treat them into the grave”: cancer physicians’ attitudes towards the use of high cost cancer medicines at the end of life

2019-10-10T09:36:22Z

“Treat them into the grave”: cancer physicians’ attitudes towards the use of high cost cancer medicines at the end of life Wiersma, M; Ghinea, N; Kerridge, I; Lipworth, W The prescribing of high cost cancer medicines at the end of life has become a focus of criticism, due primarily to concerns about the safety, efficacy and cost effectiveness of these medicines in this clinical context. In response to these concerns, a number of interventions have been proposed – frequently focused on improving physician-patient communication at the end of life. Underpinning these strategies is the assumption that the prescribing of high cost cancer medicines at the end of life is primarily the result of poor communication on the part of cancer physicians. In this paper, we explore the factors perceived by cancer physicians to be driving the use of high cost cancer medicines at the end of life. Drawing on semi-structured interviews with 16 Australian oncologists and haematologists, we demonstrate that these physicians believe that the use of high cost medicines at the end of life is driven by multiple factors – including individual, interpersonal, socio-cultural and public policy influences. We conclude that these factors, and their interactions, need to be taken into account in the development of public policy and clinical interventions to address the use of high cost medicines at the end of life.

Clearing the air: towards agreement about access to high cost cancer medicines

2019-10-10T09:36:22Z

Clearing the air: towards agreement about access to high cost cancer medicines Lipworth, W; Ghinea, N; Kerridge, I; Zalcberg, J Oncologists have an important role to play in debates about access to high cost cancer medicines. But in order for oncologists to be able to fulfil this role they need to have a solid understanding of the contexts of debates about access to high cost medicines, of the parameters that everyone can agree upon, and of the points of disagreement that need to be resolved. In this article, we offer a conceptual framework that oncologists (and other stakeholders) could use to guide more focused, systematic and ultimately mutually beneficial discussions about the subsidization of high cost cancer medicines.

The use of real world data for the research, development and evaluation of oncology precision medicines

2019-08-23T06:29:00Z

The use of real world data for the research, development and evaluation of oncology precision medicines Lewis, J; Lipworth, W; Kerridge, I Although randomized controlled trials remain the scientific ideal for determining the efficacy and safety of new treatments, they are sometimes insufficient to address the evidentiary requirements of regulators and payers. This is particularly the case when it comes to precision medicines because trials are often small, deliver incomplete insights into outcomes of most interest to policymakers (e.g. overall survival) and may fail to address other complex diagnostic and treatment related questions. Additional methods—both experimental and observational—are increasingly being used to fill critical evidentiary gaps. A number of modified early and late phase trial designs have been proposed to better support earlier biomarker validation, patient identification and selection for regulatory studies but there is still a need for confirmatory evidence from real world data sources. These data are usually provided through observational, post approval Phase 3b and 4 studies, which rely heavily on registries and other electronic data sets—most notably obtained data from electronic health records (EHRs). It is, therefore, crucial to understand what ethical, practical and scientific challenges are raised by the use of EHRs to generate evidence about precision medicines.

Community views on factors influencing medicines resource allocation: a cross sectional survey of 3080 adults in Australia.

2019-08-22T07:43:38Z

Community views on factors influencing medicines resource allocation: a cross sectional survey of 3080 adults in Australia. Chim, L; Salkeld, G; Kelly, P; Lipworth, W; Hughes, D; Stockler, M

An ethical framework for the creation, governance and evaluation of accelerated access programs

2019-12-20T01:09:19Z

An ethical framework for the creation, governance and evaluation of accelerated access programs Pace, J; Ghinea, N; Kerridge, I; Lipworth, W There are increasing demands on regulators and insurers internationally to provide access to medicines more quickly, and often on the basis of less robust evidence of safety, efficacy or cost-effectiveness than have traditionally been required. These demands arise from a number of sources, including those advocating for access to medicines for patients with life-threatening diseases, rare diseases, or subsets of common diseases and where entire populations are threatened in the context of public health emergencies. In response to these demands, policymakers have instituted a number of initiatives aimed at speeding up access to medicines, which we refer to collectively as “accelerated access” programs. While there are strong arguments for accelerated access programs, these programs also raise a number of socio-political, epistemic and moral issues. Some of these issues are common to all types of accelerated access programs, while others are specific to particular types of accelerated access. Here, we offer a conceptual framework that highlights ethically relevant similarities and differences among different kinds of accelerated access processes for the purpose of enabling ethically and politically-informed policy making.

Ethics and Epistemology in Big Data Research

2018-08-28T04:26:39Z

Ethics and Epistemology in Big Data Research Lipworth, W; Mason, PH; Kerridge, I; Ioannidis, JPA Biomedical innovation and translation are increasingly emphasizing research using “big data”. The hope is that big data methods will both speed up research and make its results more applicable to “real-world” patients and health services. While big data research has been embraced by scientists, politicians, industry and the public, numerous ethical, organizational and technical/methodological concerns have also been raised. With respect to technical and methodological concerns, there is a view that these will be resolved through sophisticated information technologies, predictive algorithms, and data analysis techniques. While such advances will likely go some way towards resolving technical and methodological issues, we believe that the epistemological issues raised by big data research have important ethical implications, and raise questions about the very possibility of big data research achieving its goals.

Caution needed in introduction of provisional approvals for medicines

2018-08-28T04:09:54Z

Caution needed in introduction of provisional approvals for medicines Pace, J; Ghinea, N; Kerridge, I; Lipworth, W The Australian government recently released its response to the Review of Medicines and Medical Devices Regulation, accepting most recommendations. One recommendation involves the introduction of provisional approvals for perceived lifesaving and innovative new treatments, allowing these to be approved on the basis of a more limited data dossier on the condition that further safety and efficacy data (including real world evidence) is collected to determine whether full approval should be granted. However, experience with similar schemes overseas raises significant questions about the safety and efficacy of products made available via these pathways; these risks are compounded by factors such as the challenges associated with the collection and use of “real world” data and the difficulties of withdrawing products from the market once patients and clinicians become familiar with them. Although there are a number of good reasons to provide patients with earlier access to medicines on the basis of provisional evidence (including providing treatment options to patients with serious illnesses and hope to those in desperate situations) we must exercise caution in the introduction of accelerated approval pathways in order to protect both current and future patients from potentially harmful and futile treatments, and ensure that healthcare systems use their resources wisely.

A will and a way to fund medicines for rare diseases: the story of human growth hormone replacement for adults with growth hormone deficiency.

2019-08-07T17:39:58Z

A will and a way to fund medicines for rare diseases: the story of human growth hormone replacement for adults with growth hormone deficiency. Lipworth, W; Ambler, G; Burt, MG; Fairchild, J; Inder, W J; Werther, G; Ho, K Growth hormone (GH) replacement therapy was recently recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme for adults with severe GH deficiency and impaired quality of life. This approval was significant for two reasons. First, the application was initiated and coordinated by a health professional working group, who prepared a ‘public interest’ submission to PBAC. Second, it resulted in a recommendation to subsidise therapy for a rare disease after two prior rejections on the basis of uncertainty about efficacy and cost effectiveness. There are important lessons to learn about the power of professional groups to drive health policy and attain funding for rare diseases.