Consent: a need for guidelines to reflect local considerations

As you point out in your Editorial (Nature 460, 933; 2009) on the distribution of human cell lines, withholding scientific material from the broader research community contravenes the basic norms of science. We do not believe, however, that standard international consent guidelines for donors are the solution to this problem and suggest that these should instead be devised on a local scale in collaboration with ethics committees to facilitate tissue distribution. Far from research being “hindered by restrictions from donors” as you suggest, people are generally willing to donate tissue for research, and even to give open-ended consent to unspecified future applications. This willingness is underpinned by donors’ faith in medical research and in their right to protection and confidentiality; the assumption is that their tissue will be used only for ‘ethical’ research. But problems can arise, for example over whether consent covers the proposed usage (at present there are many different models of consent, ranging from specific to general) and when and how tissue should be discarded (K. Aalto-Setälä et al. PLoS Biol. 7, e1000042; 2009). The answers may not always be obvious, and ethics committees (in collaboration with donors or their representatives) need to take into account the kind of tissue involved as well as the demographics and potential vulnerability of the donor or donor community, to judge the acceptability of the research proposal

The Place of Patient-Centred Care in Medical Professional Culture: A Qualitative Study

Despite widespread support, the implementation of patient-centred care (PCC) remains a challenge and it is often assumed that further clinical education and culture change are needed. To inform such efforts, we need to know whether the principles underpinning PCC accord with doctors’ personal and cultural values. In this chapter, we report the results of a qualitative interview study of clinicians, conducted in order to establish whether PCC emerges in the narratives of Australian doctors, and, if so, how. Our findings suggest that doctors both understand and value the principles underpinning PCC. This suggests that patient-centeredness is part of the professional culture of medicine, and that those wanting to ensure that this patient-centeredness remains an integral part of practice for succeeding generations of doctors might need to focus not as much on education and culture change as on ensuring that there are structures and processes in place to support PCC

Societal perspective on access to publicly subsidised medicines:A cross sectional survey of 3080 adults in Australia

Background Around the world government agencies responsible for the selection and reimbursement of prescribed medicines and other health technologies are considering how best to bring community preferences into their decision making. In particular, community views about the distribution or equity of funding across the population. These official committees and agencies often have access to the best available and latest evidence on clinical effectiveness, safety and cost from large clinical trials and population-based studies. All too often they do not have access to high quality evidence about community views. We therefore, conducted a large and representative population-based survey in Australia to determine what community members think about the factors that do and should influence government spending on prescribed medicines. Methods A choice-based survey was designed to elicit the importance of individual criteria when considering the equity of government spending on prescribed medicines. A representative sample of 3080 adult Australians completed the survey by allocating a hypothetical budget to different combinations of money spent on two patient populations. Societal preferences were inferred from absolute majority responses i.e. populations with more than 50% of respondents\u27 allocation for a particular allocation criterion. Results This study shows that, all else being equal, severity of disease, diseases for which there is no alternative treatment available on the government formulary, diseases that affect patients who are not financially well off, and life-style unrelated diseases are supported by the public as resource allocation criteria. Where \u27all else is not equal\u27, participants allocated more resources to the patient population that gained considerable improvement in health and fewer resources to those that gained little improvement in health. This result held under all scenarios except for \u27end-of-life treatments\u27. Responses to cost (and corresponding number of patients treated) trade-off scenarios indicated a significant reduction in the proportion of respondents choosing to divide resources equally and a shift in preference towards devoting resources to the population that were more costly to treat for all criteria with the exception of severity of disease. Conclusions The general public have clear views on what\u27s fair in terms of government spending on prescribed medicines. In addition to supporting the application of the \u27rule of rescue\u27, important considerations for government spending included the severity of disease being treated, diseases for which there is no alternative treatment available on the government formulary, diseases that affect patients who are not financially well off and life-style unrelated diseases. This study shows that the general public are willing to share their views on what constitutes an equitable allocation of the government\u27s drug budget. The challenge remains to how best to consider those views alongside clinical and economic considerations

Community views on factors affecting medicines resource allocation:Cross-sectional survey of 3080 adults in Australia

Objective: The aim of the present study was to determine Australian community views on factors that influence the distribution of health spending in relation to medicines. Methods: A cross-sectional web-based survey was performed of 3080 adults aged ≥18 years. Participants were asked to rank, in order of importance, 12 criteria according to which medicines funding decisions may be made. Results: Of all respondents, 1213 (39.4%) considered disease severity to be the most important prioritisation criterion for funding a new medicine. This was followed by medicines treating a disease affecting children (13.2%) and medicines for cancer patients (9.1%). Medicines targeting a disease for which there is no alternative treatment available received highest priority from 8.6% of respondents. The remaining eight prioritisation criteria were each assigned a top ranking from 6.6% to 1.7% of respondents. Medicines targeting a disease for which there is no alternative treatment available were ranked least important by 7.7% of respondents, compared with 2.4%, 1.9% and 1.0% for medicines treating severe diseases, diseases affecting children and cancer respectively. \u27End-of-life treatments\u27 and \u27rare disease therapies\u27 received the least number of highest priority rankings (2.0% and 1.7% respectively). Conclusions: These results provide useful information about public preferences for government spending on prescribed medicines. Understanding of public preferences on the funding of new medicines will help the Pharmaceutical Benefits Advisory Committee and government determine circumstances where greater emphasis on equity is required and help inform medicines funding policy that best meets the needs of the Australian population. What is known about this topic?: There is increased recognition of the importance of taking into account public preferences in the heath technology assessment (HTA) decision-making process. What does this paper add?: The Australian public view the severity of disease to be the most important funding prioritisation criterion for medicines, followed by medicines used to treat children or to treat cancer. What are the implications for practitioners?: The general public are capable of giving opinions on distributional preferences. This information can help inform medicines funding policy and ensure that it is consistent with the values of the Australian population

The Role of Personalised Choice in Decision Support: A Randomized Controlled Trial of an Online Decision Aid for Prostate Cancer Screening.

IMPORTANCE: Decision support tools can assist people to apply population-based evidence on benefits and harms to individual health decisions. A key question is whether "personalising" choice within decisions aids leads to better decision quality. OBJECTIVE: To assess the effect of personalising the content of a decision aid for prostate cancer screening using the Prostate Specific Antigen (PSA) test. DESIGN: Randomized controlled trial. SETTING: Australia. PARTICIPANTS: 1,970 men aged 40-69 years were approached to participate in the trial. INTERVENTION: 1,447 men were randomly allocated to either a standard decision aid with a fixed set of five attributes or a personalised decision aid with choice over the inclusion of up to 10 attributes. OUTCOME MEASURES: To determine whether there was a difference between the two groups in terms of: 1) the emergent opinion (generated by the decision aid) to have a PSA test or not; 2) self-rated decision quality after completing the online decision aid; 3) their intention to undergo screening in the next 12 months. We also wanted to determine whether men in the personalised choice group made use of the extra decision attributes. RESULTS: 5% of men in the fixed attribute group scored 'Have a PSA test' as the opinion generated by the aid, as compared to 62% of men in the personalised choice group (χ2 = 569.38, 2df, p< 0001). Those men who used the personalised decision aid had slightly higher decision quality (t = 2.157, df = 1444, p = 0.031). The men in the personalised choice group made extensive use of the additional decision attributes. There was no difference between the two groups in terms of their stated intention to undergo screening in the next 12 months. CONCLUSIONS: Together, these findings suggest that personalised decision support systems could be an important development in shared decision-making and patient-centered care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12612000723886

The Deadly Business of an Unregulated Global Stem Cell Industry

In 2016, the Office of the State Coroner of New South Wales released its report into the death of an Australian woman, Sheila Drysdale, who had died from complications of an autologous stem cell procedure at a Sydney clinic. In this report, we argue that Mrs Drysdale's death was avoidable, and it was the result of a pernicious global problem of an industry exploiting regulatory systems to sell unproven and unjustified interventions with stem cells.Research for this paper was supported with the funding from an Australian Research Council Linkage Project Grant (LP150100739) and the National University of Singapore, Office of the Deputy President (Research and Technology)—Humanities and Social Sciences Research Fund (WBS: R-171-000-055-646)

Decoding disclosure: comparing conflict of interest policy among the United States, France, and Australia

&quot;Sunshine&quot; policy, aimed at making financial ties between health professionals and industry publicly transparent, has recently gone global. Given that transparency is not the sole means of managing conflict of interest, and is unlikely to be effective on its own, it is important to understand why disclosure has emerged as a predominant public policy solution, and what the effects of this focus on transparency might be. We used Carol Bacchi\u27s problem-questioning approach to policy analysis to compare the Sunshine policies in three different jurisdictions, the United States, France and Australia. We found that transparency had emerged as a solution to several different problems including misuse of tax dollars, patient safety and public trust. Despite these differences in the origins of disclosure policies, all were underpinned by the questionable assumption that informed consumers could address conflicts of interest. We conclude that, while transparency reports have provided an unprecedented opportunity to understand the reach of industry within healthcare, policymakers should build upon these insights and begin to develop policy solutions that address systemic commercial influence

Rules of Engagement: Journalists’ attitudes to industry influence in health news reporting.

Health-related industries use a variety of methods to influence health news, including the formation and maintenance of direct relationships with journalists. These interactions have the potential to subvert news reporting such that it comes to serve the interests of industry in promoting their products, rather than the public interest in critical and accurate news and information. Here we report the findings of qualitative interviews conducted in Sydney, Australia, in which we examined journalists’ experiences of, and attitudes towards, their relationships with health-related industries. Participants’ belief in their ability to manage industry influence and their perceptions of what it means to be unduly influenced by industry raise important concerns relating to the psychology of influence and the realities of power relationships between industry and journalists. The analysis also indicates ways in which concerned academics and working journalists might establish more fruitful dialogue regarding the role of industry in health-related news and the extent to which increased regulation of journalist-industry relationships might be needed.NHMR