Patients' understanding of risk associated with medication use: impact of European Commission guidelines and other risk scales

Patients want and need comprehensive and accurate information about their medicines so that they can participate in decisions about their healthcare: In particular, they require information about the likely risks and benefits that are associated with the different treatment options. However, to provide this information in a form that people can readily understand and use is a considerable challenge to healthcare professionals. One recent attempt to standardise the Language of risk has been to produce sets of verbal descriptors that correspond to specific probability ranges, such as those outlined in the European Commission (EC) Pharmaceutical Committee guidelines in 1998 for describing the incidence of adverse effects. This paper provides an overview of a number of studies involving members of the general public, patients, and hospital doctors, that evaluated the utility of the EC guideline descriptors (very common, common, uncommon, rare, very rare). In all studies it was found that people significantly over-estimated the likelihood of adverse effects occurring, given specific verbal descriptors. This in turn resulted in significantly higher ratings of their perceived risks to health and significantly lower ratings of their likelihood of taking the medicine. Such problems of interpretation are not restricted to the EC guideline descriptors. Similar levels of misinterpretation have also been demonstrated with two other recently advocated risk scales (Caiman's verbal descriptor scale and Barclay, Costigan and Davies' lottery scale). In conclusion, the challenge for risk communicators and for future research will be to produce a language of risk that is sufficiently flexible to take into account different perspectives, as well as changing circumstances and contexts of illness and its treatments. In the meantime, we urge the EC and other legislative bodies to stop recommending the use of specific verbal labels or phrases until there is a stronger evidence base to support their use.

The ethical challenges of ubiquitous healthcare

Ubiquitous healthcare is an emerging area of technology that uses a large number of environmental and patient sensors and actuators to monitor and improve patients’ physical and mental condition. Tiny sensors gather data on almost any physiological characteristic that can be used to diagnose health problems. This technology faces some challenging ethical questions, ranging from the small-scale individual issues of trust and efficacy to the societal issues of health and longevity gaps related to economic status. It presents particular problems in combining developing computer/information/media ethics with established medical ethics. This article describes a practice-based ethics approach, considering in particular the areas of privacy, agency, equity and liability. It raises questions that ubiquitous healthcare will force practitioners to face as they develop ubiquitous healthcare systems. Medicine is a controlled profession whose practise is commonly restricted by government-appointed authorities, whereas computer software and hardware development is notoriously lacking in such regimes.

Modelling the likely impact of healthy eating guidelines on agricultural production and land use in England and Wales

Quadratic programming techniques were applied to household food consumption data in England and Wales to estimate likely changes in diet under healthy eating guidelines, and the consequences this would have on agriculture and land use in England and Wales. The first step entailed imposing nutrient restrictions on food consumption following dietary recommendations suggested by the UK Department of Health. The resulting diet was used, in a second step as a proxy for demand in agricultural commodities, to test the impact of such a scenario on food production and land use in England and Wales and the impacts of this on agricultural landscapes. Results of the diet optimisation indicated a large drop in consumption of foods rich in saturated fats and sugar, essentially cheese and sugar-based products, along with lesser cuts of fat and meat products. Conversely, consumption of fruit and vegetables, cereals, and flour would increase to meet dietary fibre recommendations. Such a shift in demand would dramatically affect production patterns: the financial net margin of England and Wales agriculture would rise, due to increased production of high market value and high economic margin crops. Some regions would, however, be negatively affected, mostly those dependent on beef cattle and sheep production that could not benefit from an increased demand for cereals and horticultural crops. The effects of these changes would also be felt in upstream industries, such as animal feed suppliers. While arable dominated landscapes would be little affected, pastoral landscapes would suffer through loss of grazing management and, possibly, land abandonment, especially in upland areas.

Do in vivo terahertz imaging systems comply with safety guidelines?

Techniques for the coherent generation and detection of electromagnetic radiation in the far infrared, or terahertz, region of the electromagnetic spectrum have recently developed rapidly and may soon be applied for in vivo medical imaging. Both continuous wave and pulsed imaging systems are under development, with terahertz pulsed imaging being the more common method. Typically a pump and probe technique is used, with picosecond pulses of terahertz radiation generated from femtosecond infrared laser pulses, using an antenna or nonlinear crystal. After interaction with the subject either by transmission or reflection, coherent detection is achieved when the terahertz beam is combined with the probe laser beam. Raster scanning of the subject leads to an image data set comprising a time series representing the pulse at each pixel. A set of parametric images may be calculated, mapping the values of various parameters calculated from the shape of the pulses. A safety analysis has been performed, based on current guidelines for skin exposure to radiation of wavelengths 2.6 µm–20 mm (15 GHz–115 THz), to determine the maximum permissible exposure (MPE) for such a terahertz imaging system. The international guidelines for this range of wavelengths are drawn from two U.S. standards documents. The method for this analysis was taken from the American National Standard for the Safe Use of Lasers (ANSI Z136.1), and to ensure a conservative analysis, parameters were drawn from both this standard and from the IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields (C95.1). The calculated maximum permissible average beam power was 3 mW, indicating that typical terahertz imaging systems are safe according to the current guidelines. Further developments may however result in systems that will exceed the calculated limit. Furthermore, the published MPEs for pulsed exposures are based on measurements at shorter wavelengths and with pulses of longer duration than those used in terahertz pulsed imaging systems, so the results should be treated with caution.

Laughter in the Dark: ethical aspects of drama education

This chapter considers two questions. Firstly, in what ways might drama be an effective medium through which to explore difficult and sensitive issues that concern teenagers? And secondly, what ethical questions surround the use of drama to explore such issues? A practical workshop on teenage suicide is used as a platform for a discussion on the use and implications of different drama strategies and the role of humour as a critical lens and distancing device. The work of actual teenagers is used to illustrate the effectiveness of the techniques in both raising awareness and facilitating both critical and creative responses to the delicate issue explored in the workshop.

Ensuring operational compliance and ethical responsibility in the regulation of ART: the HFEA, past, present, and future

Under the Public Bodies Bill 2010, the HFEA, cornerstone in the regulation of assisted reproduction technologies (ART) for the last twenty years, is due to be abolished. This implies that there is no longer a need for a dedicated regulator for ART and that the existing roles of the Authority as both operational compliance monitor, and instance of ethical evaluation, may be absorbed by existing healthcare regulators. This article presents a timely analysis of these disparate functions of the HFEA, charting reforms adopted in 2008 and assessing the impact of the current proposals. Taking assisted conception treatment as the focus activity, it will be shown that the last few years have seen a concentration on the HFEA as a technical regulator based upon the principles of Better Regulation, with little analysis of how the ethical responsibility of the Authority fits into this framework. The current proposal to abolish the HFEA continues to fail to address this crucial question. Notwithstanding the fact that the scope of the Authority's ethical role may be questioned, its abolition requires that the Government consider what alternatives exists - or need to be put in place - to provide both responsive operational regulation and a forum for ethical reflection and decision-making in an area which continues to pose regulatory challenges