Priority allocation of pandemic influenza vaccines in Australia - Recommendations of 3 community juries.

BACKGROUND: Pandemic planning has historically been oriented to respond to an influenza virus, with vaccination strategy being a key focus. As the current COVID-19 pandemic plays out, the Australian government is closely monitoring progress towards development of SARS-CoV2 vaccines as a definitive intervention. However, as in any pandemic, initial supply will likely be exceeded by demand due to limited manufacturing output. METHODS: We convened community juries in three Australian locations in 2019 to assess public acceptability and perceived legitimacy of influenza pandemic vaccination distribution strategies. Preparatory work included literature reviews on pandemic vaccine allocation strategies and on vaccine allocation ethics, and simulation modelling studies. We assumed vaccine would be provided to predefined priority groups. Jurors were then asked to recommend one of two strategies for distributing remaining early doses of vaccine: directly vaccinate people at higher risk of adverse outcomes from influenza; or indirectly protect the general population by vaccinating primary school students, who are most likely to spread infection. RESULTS: Thirty-four participants of diverse backgrounds and ages were recruited through random digit dialling and topic-blinded social media advertising. Juries heard evidence and arguments supporting different vaccine distribution strategies, and questioned expert presenters. All three community juries supported prioritising school children for influenza vaccination (aiming for indirect protection), one by 10-2 majority and two by consensus. Justifications included that indirect protection benefits more people and is likely to be more publicly acceptable. CONCLUSIONS: In the context of an influenza pandemic, informed citizens were not opposed to prioritising groups at higher risks of adverse outcomes, but if resources and epidemiological conditions allow, achieving population benefits should be a strategic priority. These insights may inform future SARS-CoV-2 vaccination strategies.

Efficacy of m-Health for the detection of adverse events following immunization - The stimulated telephone assisted rapid safety surveillance (STARSS) randomised control trial.

INTRODUCTION: Passive surveillance is recommended globally for the detection of adverse events following immunisation (AEFI) but this has significant challenges. Use of Mobile health for vaccine safety surveillance enables a consumer-centred approach to reporting. The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) a randomised control trial (RCT) sought to evaluate the efficacy and acceptability of SMS for AEFI surveillance. METHODS: Multi-centre RCT, participants were adult vaccinees or parents of children receiving any vaccine at a trial site. At enrolment randomisation occurred to one of two SMS groups or a control group. Prompts on days 2, 7 and 14 post-immunisation, were sent to the SMS group, to ascertain if a medical event following immunisation (MEFI) had occurred. No SMS's were sent to the control participants. Those in the SMS who notified an MEFI were pre-randomised to complete a computer assisted telephone interview or a web based report to determine if an AEFI had occurred whilst an AEFI in the controls was determined by a search for passive reports. The primary outcome was the AEFI detection rate in the SMS group compared to controls. RESULTS: We enrolled 6,338 participants, who were equally distributed across groups and who received 11,675 vaccines. The SMS group (4,225) received 12,675 surveillance prompts with 9.8% being non-compliant and not responding. In those that responded 90% indicated that no MEFI had been experienced and 184 had a verified AEFI. 6 control subjects had a reported AEFI. The AEFI detection rate was 13 fold greater in the SMS group when compared with controls (4.3 vs 0.3%). CONCLUSION: We have demonstrated that the STARSS methodology improves AEFI detection. Our findings should inform the wider use of SMS-based surveillance which is particularly relevant since establishing robust and novel pharmacovigilance systems is critical to monitoring novel vaccines which includes potential COVID vaccines.

Consumer acceptability and validity of m-Health for the detection of adverse events following immunization - The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial.

INTRODUCTION: Monitoring for adverse events following immunisation (AEFI) is critical for vaccine pharmacovigilance. Given the global and expanding availability of mobile phones their utility for consumer-based vaccine safety surveillance is of interest but little is known about consumer acceptability. This study nested within the Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial sought to evaluate the acceptability of SMS for AEFI surveillance. METHODS: The primary STARSS study was a multi-centre RCT evaluating the efficacy of repeated SMS prompts for AEFI surveillance with participants being adult vaccinees or parents of children receiving any vaccine. This nested study enrolled primary RCT participants who completed a detailed computer assisted telephone interview to determine their attitudes towards SMS-based surveillance and ascertain their knowledge and attitudes toward vaccine safety, efficacy, data privacy and use of electronic health records. Attitudes to surveillance and related behaviour were used as measures of acceptability. RESULTS: 20% (1200/6555) of the participants were enrolled and 1139 completed the full-length questionnaire. 96% indicated that SMS-based surveillance after immunisation to check the safety of the vaccine "should be done" but 62% of all respondents said it should be done but consent should be sought first. Neither vaccine safety attitudes nor attitudes toward privacy were associated with opposition to SMS-based surveillance. In terms of SMS related behaviour demographic rather than attitudinal factors were associated with non-compliance. CONCLUSION: Overall, the attitude towards SMS-based surveillance was very favourable. Experiencing the SMS surveillance has the effect of reducing opposition to an SMS surveillance system, and at the same time increasing the likelihood of a preference for prior consent. Detection of a vaccine safety signal could be impeded in particular demographic groups who are non-compliant and we should undertake further research to understand why these groups are non-compliant and how this can be improved.

Aboriginal community controlled health organisations address health equity through action on the social determinants of health of Aboriginal and Torres Strait Islander peoples in Australia.

BACKGROUND: Indigenous populations globally are continually striving for better health and wellbeing due to experiencing significant health and social inequities. The social determinants of health are important contributors to health outcomes. Comprehensive primary health care that is governed and delivered by Indigenous people extends beyond the biomedical model of care to address the social determinants of health. Aboriginal Community Controlled Health Organisations (ACCHOs) are known to provide culturally informed, holistic health services that directly and indirectly address the social determinants of health. The range and extent of their activities in addressing the social determinants of health, however, is not well documented. METHODS: The most recent ACCHO annual reports were retrieved online or by direct correspondence. For coding consistency, a dictionary informed by the World Health Organization's Conceptual Framework for Action on the Social Determinants of Health was developed. A document and textual analysis of reports coded ACCHO activities and the determinants of health they addressed, including intermediary determinants, socio-economic position and/or socio-political context. Summary statistics were reported. Representative quotes illustrating the unique nature of ACCHO service provision in addressing the social determinants of health were used to contextualise the quantitative findings. RESULTS: Sixty-seven annual reports were collected between 2017 and 2018. Programs were delivered to population groups across the life span. Fifty three percent of reports identified programs that included work at the socio-political level and all annual reports described working to improve socioeconomic position and intermediary determinants of health through their activities. Culture had a strong presence in program delivery and building social cohesion and social capital emerged as themes. CONCLUSIONS: This study provides evidence of the considerable efforts of the ACCHO sector, as a primary health care provider, in addressing the social determinants of health and health inequity experienced by Indigenous communities. For the Aboriginal and Torres Strait Islander population, ACCHOs not only have an essential role in addressing immediate healthcare needs but also invest in driving change in the more entrenched structural determinants of health. These are important actions that are likely to have an accumulative positive effect in closing the gap towards health equity.

Legal impediments to data linkage.

Large numbers of electronic health data collections have been accumulated by both government and non-government agencies and organisations. Such collections primarily assist with the management of health services and the provision of health care programs, with only a minority of these data collections also intended for research purposes. A number of constraints are placed on access to such data for the purposes of research, including data linkage. This article examines those factors arising from the intricacies of Australia's privacy legislation landscape which impede access to such collections. The relevant issues discussed include issues relating to the existence of multiple privacy and health privacy Acts, the recommendations made by the Australian Law Reform Commission in relation to the Privacy Act 1988 (Cth) and the constraints placed on the conduct of data-linkage research which arise from legislation that relates specifically to certain data collections.

Ethical issues in funding research and development of drugs for neglected tropical diseases.

Neglected and tropical diseases, pervasive in developing countries, are important contributors to global health inequalities. They remain largely untreated due to lack of effective and affordable treatments. Resource-poor countries cannot afford to develop the public health interventions needed to control neglected diseases. In addition, neglected diseases do not represent an attractive market for pharmaceutical industry. Although a number of international commitments, stated in the Millennium Development Goals, have been made to avert the risk of communicable diseases, tropical diseases still remain neglected due to delays in international assistance. This delay can be explained by the form international cooperation has generally taken, which is limited to promoting countries' national interests, rather than social justice at a global level. This restricts the international responsibility for global inequalities in health to a humanitarian assistance. We propose an alternative view, arguing that expanding the scope of international cooperation by promoting shared health and economic value at a global level will create new opportunities for innovative, effective and affordable interventions worldwide. It will also promote neglected diseases as a global research priority. We build our argument on a proposal to replace the patenting system that currently regulates pharmaceutical research with a global fund to reward this research based on actual decreases in morbidity and mortality at a global level. We argue that this approach is beneficent because it will decrease global health inequalities and promote social justice worldwide.

Conflicts of interest in divisions of general practice.

Community-based healthcare organisations manage competing, and often conflicting, priorities. These conflicts can arise from the multiple roles these organisations take up, and from the diverse range of stakeholders to whom they must be responsive. Often such conflicts may be titled conflicts of interest; however, what precisely constitutes such conflicts and what should be done about them is not always clear. Clarity about the duties owed by organisations and the roles they assume can help identify and manage some of these conflicts. Taking divisions of general practice in Australia as an example, this paper sets out to distinguish two main types of conflicts of interest, so that they may be more clearly identified and more effectively managed.

What makes a good GP? An empirical perspective on virtue in general practice.

This paper takes a virtuist approach to medical ethics to explore, from an empirical angle, ideas about settled ways of living a good life. Qualitative research methods were used to analyse the ways in which a group of 15 general practitioners (GPs) articulated notions of good doctoring and the virtues in their work. I argue that the GPs, whose talk is analysed here, defined good general practice in terms of the ideals of accessibility, comprehensiveness, and continuity. They regarded these ideals significant both for the way they dealt with morally problematic situations and for how they conducted their professional lives more generally. In addition, I argue that the GPs who articulated these ideals most clearly were able to, in part, because they shared the experience of working in rural areas. This experience helped them to develop an understanding of the nature of general practice that their urban colleagues were less able to draw on. In that sense, the structural and organisational framework of general practice in rural areas provided the context for their understanding of ideals in general practice.

Doctors' views about the importance of shared values in HIV positive patient care: a qualitative study.

Robert Veatch has proposed a model of the doctor-patient relationship that has as its foundation the sharing of values between the doctor and the patient. This paper uses qualitative research conducted with six doctors involved in the long term, specialised care of HIV positive patients in South Australia to explore the practical application of Veatch's value sharing model in that setting. The research found that the doctors in this study linked "values" with sexual identity such that they defined value sharing, in part, as a shared set of values and beliefs about sexual identity and practices. They voluntarily identified themselves as either homosexual or heterosexual and they regarded the relation between their own sexual identity and that of their patients as important for the provision of quality care. None of the doctors thought that value sharing, in the way they defined it, was essential to the clinical relationship, but the homosexual doctors attributed a greater degree of importance to it than their heterosexual colleagues.

An ethics core curriculum for Australasian medical Schools.

Teaching ethics incorporates teaching of knowledge as well as skills and attitudes. Each of these requires different teaching and assessment methods. A core curriculum of ethics knowledge must address both the foundations of ethics and specific ethical topics. Ethical skills teaching focuses on the development of ethical awareness, moral reasoning, communication and collaborative action skills. Attitudes that are important for medical students to develop include honesty, integrity and trustworthiness, empathy and compassion, respect, and responsibility, as well as critical self-appraisal and commitment to lifelong education.

Should medical students act as surrogate patients for each other?

Until recently, most clinical teachers and medical students have regarded using medical students as surrogate patients for peer teaching of physical examinations and clinical skills as practical and uncontroversial. Recent changes to medical curricula and changes in hospitalized patient populations have led to questions about the ethical acceptability of this practice. This paper explores the ethical issues inherent in the use of medical students as surrogate patients. It suggests that, ethically, there are parallels with two situations: when students conduct physical examinations on patients and when students participate as subjects in research. Drawing on accepted ethical practice in these two germane areas, the paper argues that there are both ethical strengths and weaknesses in the practice of using students as surrogate patients. Strategies to promote free and informed involvement of students as surrogate patients are suggested.

Casuistry as bioethical method: an empirical perspective.

This paper examines the role that casuistry, a model of bioethical reasoning revived by Jonsen and Toulmin, plays in ordinary moral reasoning. I address the question: 'What is the evidence for contemporary casuistry's claim that everyday moral reasoning is casuistic in nature?' The paper begins with a description of the casuistic method, and then reviews the empirical arguments Jonsen and Toulmin offer to show that every-day moral decision-making is casuistic. Finally, I present the results of qualitative research conducted with 15 general practitioners (GPs) in South Australia, focusing on the ways in which these GP participants used stories and anecdotes in their own moral reasoning. This research found that the GPs interviewed did use a form of casuistry when talking about ethical dilemmas. However, the GPs' homespun casuistry often lacked one central element of casuistic reasoning--clear paradigm cases on which to base comparisons. I conclude that casuistic reasoning does appear to play a role in every-day moral decision-making, but that it is a more subdued role than perhaps casuists would like.

What makes a problem an ethical problem? An empirical perspective on the nature of ethical problems in general practice.

Whilst there has been considerable debate about the fit between moral theory and moral reasoning in everyday life, the way in which moral problems are defined has rarely been questioned. This paper presents a qualitative analysis of interviews conducted with 15 general practitioners (GPs) in South Australia to argue that the way in which the bioethics literature defines an ethical dilemma captures only some of the range of lay views about the nature of ethical problems. The bioethics literature has defined ethical dilemmas in terms of conflict and choice between values, beliefs and options for action. While some of the views of some of the GPs in this study about the nature of their ethical dilemmas certainly accorded with this definition, other explanations of the ethical nature of their problems revolved around the publicity associated with the issues they were discussing, concern about their relationships with patients, and anxiety about threats to their integrity and reputation. The variety of views about what makes a problem a moral problem indicates that the moral domain is perhaps wider and richer than mainstream bioethics would generally allow.

Application of the privacy principles to general practice.

BACKGROUND: There are escalating requirements for general practitioners to comply with recognised privacy principles. With amendments to the Commonwealth Privacy Act (1988) imminent, there is an urgent need to formulate methods for applying these principles to general practice. OBJECTIVE: The article provides an explanation of the origins of the privacy principles and a simple self audit which general practitioners can use to assess the extent to which their usual practices conform with them. DISCUSSION: A careful review of the principles indicates that new measures will be needed before most general practices will be able to approach required standards of conduct. Practical strategies for achieving best practice are discussed and challenges confronting general practices in applying the principles are canvassed. Ethics committees should be used more often to provide independent review of practice policies and proposals to use patient information in new ways. General practitioners can expect increasing scrutiny and debate concerning confidentiality. In order to maintain patient trust in GPs as responsible data custodians, the privacy principles can be seen as a quality improvement tool.

Handling information ethically. Some strategies for discussion.

BACKGROUND: A lack of consensus currently exists about which uses of patient data require informed consent or review by a human research ethics committee. However, any use of patient data other than for clinical care, requires the consent of the patient. OBJECTIVE: The aim of this paper is to discuss strategies for strengthening current practices regarding the use of patient information in general practice research, evaluation and audit. DISCUSSION: Increasing community discussion and debate with respect to the use of patient data for research and evaluation is a pressing issue. Divisions of general practice are well placed to lead in this debate given the extent of community representation in many divisions' activities. Development of guidelines for use by those undertaking research and evaluation activities in general practice, based upon the Privacy Principles, will ensure a high standard of protection for patients. Community based Human Research Ethics Committees may be an appropriate way of providing education and training as well as a review of general practice research and related activities.

Handling information. Some ethical issues.

BACKGROUND: General practitioners are increasingly involved in a range of activities which require the use of data from patients' case notes. These activities include audit, evaluation and research. Any use of patient data has the potential to breach patient confidentiality and privacy. However, at present the requirements in terms of obtaining informed consent vary. Research is usually acknowledged as requiring consent, but this is not always the case for audit and evaluation activities. OBJECTIVES: The aim of this paper is to define audit, evaluation and research activities in general practice and to clarify the ethical issues involved in using patient data for these purposes. We argue that the ethical issues raised by accessing patient case notes are similar for all of these activities. DISCUSSION: The ethical obligation to obtain patient consent prior to accessing or using patient information is the same for many general practice audit, evaluation and research activities. However, the avenues for obtaining ethical clearance may be hard to access for GPs. In addition, the special relationship between patients and their GP and the requirements specified by health research ethics committees such as de-identification of case notes create problems for these activities in general practice.

Ethics, DRGs and medical record administrators.

Medical record administrators in the United States have documented a range of ethical problems which they have experienced as a result of the advent of DRGs. This paper considers the similarities and differences between the Australian and United States experience of DRGs, and the implications of these for Australian medical record administrators. Some ethical problems are described, and it is argued that these problems relate particularly to power imbalances between medical record administrators and other health professions.