Publications by authors named "Wendy Lipworth"

Medicine has always existed in a marketplace, and there have been extensive discussions about the ethical implications of commerce in health care. For the most part, this discussion has focused on health professionals' interactions with pharmaceutical and other health technology industries, with less attention given to other types of commercial influences, such as corporatized health services and fee-for-service practice. This is a significant lacuna because in many jurisdictions, some or all of healthcare is delivered in the private sector.

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Article Synopsis
  • In Australia and the UK, the rise of commercial and corporate models in assisted reproduction has created a marketplace that enhances patient choice, though this commercialization may compromise care quality.
  • Current regulations focus mainly on the relationships between doctors and patients, or clinics and consumers, neglecting conflicts of interest between clinic-corporations, shareholders, and their duties to patients.
  • The authors propose new regulatory frameworks that better define the responsibilities of both corporations and clinicians to patients and society, and suggest approaches suitable for both Australia's multi-jurisdictional system and the UK’s single jurisdiction.
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In recent years, concerns about the financial burdens of health care and growing recognition of the relevance of cost to decision making and patient experience have increasingly focused attention on financial 'transparency' and disclosure of costs to patients. In some jurisdictions, there have been calls not only for timely disclosure of costs information, but also for 'informed financial consent'. However, simply putting the 'financial' into 'informed consent' and invoking an informed consent standard for cost information encounters several ethical, legal, and practical difficulties.

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The objective of this scoping review was to systematically review the literature on how non-financial conflicts of interest (nfCOI) are defined and evaluated, and the strategies suggested for their management in health-related and biomedical journals. PubMed, Embase, Scopus and Web of Science were searched for peer reviewed studies published in English between 1970 and December 2023 that addressed at least one of the following: the definition, evaluation, or management of non-financial conflicts of interest. From 658 studies, 190 studies were included in the review.

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Research Question: What are the views and experiences of patient and expert stakeholders on the positive and negative impacts of commercial influences on the provision of assisted reproductive technology (ART) services, and what are their suggestions for governance reforms?

Design: Semi-structured interviews were conducted with 31 ART industry experts from across Australia and New Zealand and 25 patients undergoing ART from metropolitan and regional Australia, between September 2020 and September 2021. Data were analysed using thematic analysis.

Results: Expert and patient participants considered that commercial forces influence the provision of ART in a number of positive ways - increasing sustainability, ensuring consistency in standards and providing patients with greater choice.

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New technologies can help older persons age in place and support their caregivers. However, they need to be accepted by the end-users to do so. Technology acceptance models, such as TAM and UTAUT and their extensions, use factors like performance expectancy and effort expectancy to explain acceptance.

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Research Question: What factors do assisted reproductive terchnology (ART) providers take into account when they make decisions about offering 'add-ons'?

Design: A qualitative analysis of interviews with 31 ART professionals, focusing on their views and experiences in relation to add-ons, including the factors that are considered when doctors make decisions about their use.

Results: The participants reported that a range of considerations are taken into account when it comes to justifying the use of a particular add-on in a given circumstance, including the likelihood of benefit and harm, patients' perceived psychological needs and preferences, and organizational expectations. Importantly, patient preferences, psychological factors and low risk of harm appear to be stronger motivations than increasing the likelihood of a live birth or the desire to innovate.

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Clinical trials play a crucial role in generating evidence about healthcare interventions and improving outcomes for current and future patients. For individual trial participants, however, there are inevitably trade-offs involved in clinical trial participation, given that trials have traditionally been designed to benefit future patient populations rather than to offer personalised care. Failure to understand the distinction between research and clinical care and the likelihood of benefit from participation in clinical trials has been termed the 'therapeutic misconception'.

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Innovation is a key driver of care provision in assisted reproductive technologies (ART). ART providers offer a range of add-on interventions, aiming to augment standard in vitro fertilization protocols and improve the chances of a live birth. Particularly in the context of commercial provision, an ever-increasing array of add-ons are marketed to ART patients, even when evidence to support them is equivocal.

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Article Synopsis
  • Evidence indicates that doctors often adminster unproven assisted reproductive technologies (ART) and interventions due to strong patient demand, even when the success rates are low.
  • The paper explores the ethical considerations surrounding patient-led demands in ART, questioning if it's morally justifiable for doctors to comply with these requests.
  • The authors argue that doctors have a unique professional responsibility to balance patient demands with the ethical implications of providing contested interventions, especially within commercial healthcare environments.
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Context: In vitro fertilisation (IVF) is now a common assisted reproductive technology (ART) procedure globally, with 8 million children alive today having been conceived utilising IVF. For many patients, IVF is a difficult experience with many discontinuing treatment because of emotional, relationship and financial stress, or intolerable physical side effects of hormone treatments.

Design And Participants: A qualitative study, in which 31 professionals and 25 patients from the ART sector in Australia were interviewed.

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With the increasing costs of drug development, repurposing of low-cost medicines for new indications has never been more important. However, there are multiple barriers to repurposing, particularly for off-patent medicines, and limited incentives for the pharmaceutical industry to sponsor registration and public subsidy listing. Here, we explore these barriers and their consequences and provide examples of successful repurposing strategies.

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Novel medicines are entering the market rapidly and are increasingly being used alone or in combination to treat illnesses of every sort. While transforming the lives of many patients, these new therapies have also forced us to reconsider the way we evaluate, use and fund medicines. This article offers a primer to help practitioners understand how the therapeutic landscape is changing and how this might impact the evidence generation, access to interventions, patient experience and quality of care.

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Qualitative studies on assisted reproductive technology commonly focus on the perspectives of participants living in major metropolises. In doing so, the experiences of those living outside major cities, and the unique way conditions of spatiality shape access to treatment, are elided. In this paper, we examine how location and regionality in Australia impact upon access and experience of reproductive services.

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Many factors influence patients' decisions to participate in clinical trials. For many, the primary motivation is the possibility that they might derive some benefit from participation. This is particularly true for patients with limited treatment options, such as patients with advanced cancer.

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Background: It is common for doctors to engage in clinical innovation-i.e. to use novel interventions that differ from standard practice, and that have not yet been shown to be safe or effective according to the usual standards of evidence-based medicine-in the belief that this will benefit their patients.

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Background: In many countries, ART service provision is a commercial enterprise. This has benefits, for example, creating efficiencies and economies of scale, but there are also concerns that financial imperatives can negatively impact patient care. The commercialization of ART is often conceptualized as being driven solely by the financial interests of companies and clinicians, but there are in fact many complex and intersecting socio-political demands for ART that have led to, sustain and shape the industry.

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This section examines recent reforms to the regulatory framework for biologicals contained in the Therapeutic Goods Act 1989 (Cth) in the context of the "New Frontier" of reform envisioned in a report completed by the Commonwealth Government in 2021. It compares Australia's proposed reform of the approval processes for biologicals to similar reforms that have been made over the last three decades in the United States and the European Union. It places the Australian reforms in the context of the commercialisation of regenerative medicine and identifies several potential shortcomings of the proposed reforms and reports on the current lack of data on the processes of expedited approvals in Australia more generally.

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Corruption is a word used loosely to describe many kinds of action that people find distasteful. We prefer to reserve it for the intentional misuse of the good offices of an established social entity for private benefit, posing as fair trading. The currency of corruption is not always material or financial.

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Waitzberg and colleagues' participants articulate a wide range of strategies to manage tensions between clinical and economic obligations. There are, however, three notable absences in the data. First, all strategies described by participants are underpinned by the assumption that clinical (and associated administrative) practices to either align with economic considerations or be made more compatible with them.

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