Wendy Lipworth

Beliefs and beyond: what can we learn from qualitative studies of lay people’s understandings of cancer risk?

Background  Clinicians and public health professionals are centrally concerned with mediating risk. However, people often resist the risk‐related information that is communicated to them by experts, or have their own models of risk that conflict with expert views. Quantitative studies have clearly demonstrated the importance of health beliefs and various cognitive and emotional processes in shaping risk perception. More recently, a growing body of qualitative research has emerged, exploring lay conceptualizations, experiences and constructions of cancer risk. To date, this literature has not been synthesized.

Consent in crisis: the need to reconceptualize consent to tissue banking research

The issues surrounding consent to tissue banking research in Australia are complex and have created a forum of intense debate, thus providing a window of opportunity to critically appraise and challenge standard models of consent for research in general and for tissue banking research in particular. The usual practical difficulties associated with meeting the criteria for valid consent to research (including adequate information provision and voluntariness) are amplified in the case of tissue banking research. A number of models, based on widely accepted ethical principles, have been proposed to improve the process of obtaining consent to tissue banking research, all of which assume that the consent of individual tissue donors is needed to meet the criteria for valid consent. Feminist and communitarian theories use many of the same criteria for valid consent but interpret these criteria differently and de‐emphasize the importance of individual autonomy as the central criterion for valid consent. An enriched model of consent incorporating feminist and communitarian ideas could satisfy the currently accepted criteria for valid consent while also furthering a broader range of community values.

Can the theoretical domains framework account for the implementation of clinical quality interventions

BackgroundThe health care quality improvement movement is a complex enterprise. Implementing clinical quality initiatives requires attitude and behaviour change on the part of clinicians, but this has proven to be difficult. In an attempt to solve this kind of behavioural challenge, the theoretical domains framework (TDF) has been developed. The TDF consists of 14 domains from psychological and organisational theory said to influence behaviour change. No systematic research has been conducted into the ways in which clinical quality initiatives map on to the domains of the framework. We therefore conducted a qualitative mapping experiment to determine to what extent, and in what ways, the TDF is relevant to the implementation of clinical quality interventions.MethodsWe conducted a thematic synthesis of the qualitative literature exploring clinicians’ perceptions of various clinical quality interventions. We analysed and synthesised 50 studies in total, in five domains of clinical quality interventions: clinical quality interventions in general, structural interventions, audit-type interventions, interventions aimed at making practice more evidence-based, and risk management interventions. Data were analysed thematically, followed by synthesis of these themes into categories and concepts, which were then mapped to the domains of the TDF.ResultsOur results suggest that the TDF is highly relevant to the implementation of clinical quality interventions. It can be used to map most, if not all, of the attitudinal and behavioural barriers and facilitators of uptake of clinical quality interventions. Each of these 14 domains appeared to be relevant to many different types of clinical quality interventions. One possible additional domain might relate to perceived trustworthiness of those instituting clinical quality interventions.ConclusionsThe TDF can be usefully applied to a wide range of clinical quality interventions. Because all 14 of the domains emerged as relevant, and we did not identify any obvious differences between different kinds of clinical quality interventions, our findings support an initially broad approach to identifying barriers and facilitators, followed by a “drilling down” to what is most contextually salient. In future, it may be possible to establish a model of clinical quality policy implementation using the TDF.

Balance, Balancing, and Health:

In this article we explore the concept of balance in the context of health. We became interested in balance during a grounded theory study of lay conceptualizations of cancer risk in which participants were concerned with having a good life, which relied heavily on balancing processes. This led us to the qualitative literature about balance in the context of health, which was large and in need of synthesis. We identified 170 relevant studies and used Thomas and Harden’s technique of thematic synthesis to identify key balance-related themes and develop these into more abstract analytic categories. We found that balance and balancing were salient to people in three health-related contexts: health maintenance, disease or disability management, and lay or professional caregiving. In each of these contexts, balance or imbalance could be a state or a process. In addition, those using the word balance had either an internally or externally focused orientation to the world around them. Clinicians and public health practitioners might benefit from using these insights in their research and communication.

Why might people donate tissue for cancer research? Insights from organ/tissue/blood donation and clinical research.

Little is known about why patients with cancer do or do not donate their biopsied/cancerous tissue to research. A review of the literature on motivations to participate in clinical research and to donate tissues/organs for therapeutic use may provide some insights relevant to tumour banking research. While more research is necessary, a better understanding of the factors that motivate patients to give or refuse consent to tumour banking may ultimately improve consent practices, public trust and donation rates.

It looks after me: how older patients make decisions about analgesics for osteoarthritis.

To explore the key motivators behind selection of analgesics (nonsteroidal antiinflammatory drugs [NSAIDs], acetaminophen, and complementary medications [CMs]) by patients with osteoarthritis (OA).

VALUES-BASED MEDICINE AND MODEST FOUNDATIONALISM

Philosophically, values refer to the basic commitments that justify judgements, beliefs and practices, both at the community and personal levels. The study of these kinds of values is axiology. We suggest that all people subscribe to three foundational values - survival, security and flourishing - and that these foundational values are expressed by way of concepts, systems, principles and practices that may differ substantially from culture to culture. Values can stand on their own as foundational justifications for health care and medicine. Many ethical quandaries can be better understood, even though they may remain unsolved, by reference to the foundational values that people can agree upon. This version of values-based health care has strong claims to prior logical status as a justification for the whole enterprise of health care, and values-based medicine is a part of this larger domain.Philosophically, values refer to the basic commitments that justify judgements, beliefs and practices, both at the community and personal levels. The study of these kinds of values is axiology. We suggest that all people subscribe to three foundational values – survival, security and flourishing – and that these foundational values are expressed by way of concepts, systems, principles and practices that may differ substantially from culture to culture. Values can stand on their own as foundational justifications for health care and medicine. Many ethical quandaries can be better understood, even though they may remain unsolved, by reference to the foundational values that people can agree upon. This version of values-based health care has strong claims to prior logical status as a justification for the whole enterprise of health care, and values-based medicine is a part of this larger domain.

Cancer as Rubbish: Donation of Tumor Tissue for Research

Tissue banking (or biobanking), thought by many to be an essential form of medical research, has raised a number of ethical issues that highlight a need to understand the beliefs and values of tissue donors, including the motivations underlying consent or refusal to donate. Data from our qualitative study of the legal, social, and ethical issues surrounding tumor banking in New South Wales, Australia, show that participants’ attitudes to donation of tumor tissue for research are partially captured by theories of weak altruism and social exchange. However, we argue that the psychological rewards of value transformation described by Thompson’s rubbish theory provide additional insights into participants’ attitudes to tumor donation. We believe our data provides sufficient justification for an approach to regulation of tumor banking that is aimed at fostering a relationship based on the notions of virtuous reassignment and social exchange.

Importation of generic hepatitis C therapies: bridging the gap between price and access in high-income countries

An estimated 80–150 million people are infected with hepatitis C virus (HCV) worldwide, with the highest prevalence in low-income and medium-income countries of Africa and Asia. HCV-related liver disease mortality is estimated to be half a million per annum. Chronic HCV treatment was interferon based for two decades, with the addition of ribavirin, pegylatedinterferon, and initial protease inhibitor direct acting antiviral (DAA) therapies (telaprevir, boceprevir) subsequently providing stepwise improvements in the rate of sustained virological response (SVR). Despite these improvements, interferon-containing HCV therapy uptake remained low in most countries, ranging from less than 1% to a maximum of 5% of people with chronic HCV starting therapy each year. Fortunately, the past 5 years have seen a revolution in HCV therapeutic development, with the advent of interferon-free DAA therapies, which disrupt replication through inhibition of HCV protease, polymerase, and NS5A function. Simple (single daily dosing oral regimens), highly tolerable, short-duration (8–24 weeks) regimens with extremely high efficacy (cure rates >95%) have been developed and registered internationally. Used in various combinations depending on HCV genotypes and previous treatment exposure, these include: sofosbuvir and ledipasvir; paritaprevir, ritonavir, ombitasvir, and dasabavir with or without ribavirin; sofosbuvir and daclatasvir; elbasvir and grazoprevir; and sofosbuvir and velpatasvir. There is clear evidence that HCV cure affects the risk of HCV-related liver disease and hepatocellular carcinoma. Early treatment might have greater benefit. Furthermore, as a result of the high efficacy and tolerance, and ease of delivery of these drugs, HCV treatment as prevention is being explored in some countries, particularly treatment of high-prevalence populations, such as people who inject drugs and incarcerated populations. The broad implementation of these therapeutic regimens has the potential to dramatically affect the burden of HCV-related disease globally. Indeed, new HCV treatments have been deemed so important that some (sofosbuvir, daclatasvir) were added to the 2015 WHO Essential Medicines List along with a number of their combinations. High drug pricing for interferon-free DAA regimens (up to US

Informed consent and medical ordeal: a qualitative study

93 000 per 12 week course) has limited broad implementation in the vast majority of settings, with restrictions based on liver disease stage generally introduced to reduce budget impact. Other restrictions, including those based on ongoing drug and alcohol use, have further limited access in many settings, particularly within the USA. Even in high-income countries, there is considerable diversity in access to and pricing of new HCV therapies. In the UK, spending on HCV treatment increased almost five-fold between 2014 and 2015, to £190 million. Estimates suggest that it would cost more than £4 billion to treat the estimated 214 000 people with chronic HCV in the UK at a cost of £20 000, so access has generally been restricted to those with advanced liver disease. The Australian Government has allocated AUS