Randomized trial evaluating the framing of cardiovascular risk and its impact on blood pressure control [ISRCTN87597585]

BACKGROUND: The format or frame in which the results of randomized trials are presented has been shown to influence health professional's self-reported practice. We sought to investigate the effect of framing cardiovascular risk as two different formats in a randomized trial. METHODS: We recruited 457 patients aged between 60 and 79 years with high blood pressure from 20 family practices in Avon, UK. Patients were randomized to cardiovascular risk presented either as 1) an absolute risk level (AR) or as 2) the number needed to treat to prevent an adverse event (NNT). The main outcome measures were: 1) percentage of patients in each group with a five-year cardiovascular risk ≥ 10%, 2) systolic and diastolic blood pressure, 3) intensity of prescribing of cardiovascular medication. RESULTS: Presenting cardiovascular risk as either an AR or NNT had no impact reducing cardiovascular risk at 12 month follow up, adjusted odds ratio 1.53 (95%CI 0.76 to 3.08). There was no difference between the two groups in systolic (adjusted difference 0.97 mmHg, 95%CI -2.34 mmHg to 4.29 mmHg) or diastolic (adjusted difference 0.70 mmHg, 95%CI -1.05 mmHg to 2.45 mmHg) blood pressure. Intensity of prescribing of blood pressure lowering drugs was not significantly different between the two groups at six months follow up. CONCLUSIONS: Presenting cardiovascular risk in clinical practice guidelines as either an AR or NNT had a similar influence on patient outcome and prescribing intensity. There is no difference in patient outcomes when these alternative formats of risk are used in clinical practice guidelines

Precaution or Integrated Responsibility Approach to Nanovaccines in Fish Farming? A Critical Appraisal of the UNESCO Precautionary Principle

Nanoparticles have multifaceted advantages in drug administration as vaccine delivery and hence hold promises for improving protection of farmed fish against diseases caused by pathogens. However, there are concerns that the benefits associated with distribution of nanoparticles may also be accompanied with risks to the environment and health. The complexity of the natural and social systems involved implies that the information acquired in quantified risk assessments may be inadequate for evidence-based decisions. One controversial strategy for dealing with this kind of uncertainty is the precautionary principle. A few years ago, an UNESCO expert group suggested a new approach for implementation of the principle. Here we compare the UNESCO principle with earlier versions and explore the advantages and disadvantages by employing the UNESCO version to the use of PLGA nanoparticles for delivery of vaccines in aquaculture. Finally, we discuss whether a combined scientific and ethical analysis that involves the concept of responsibility will enable approaches that can provide a supplement to the precautionary principle as basis for decision-making in areas of scientific uncertainty, such as the application of nanoparticles in the vaccination of farmed fish

Improving prescribing of antihypertensive and cholesterol-lowering drugs: a method for identifying and addressing barriers to change

BACKGROUND: We describe a simple approach we used to identify barriers and tailor an intervention to improve pharmacological management of hypertension and hypercholesterolaemia. We also report the results of a post hoc exercise and survey we carried out to evaluate our approach for identifying barriers and tailoring interventions. METHODS: We used structured reflection, searched for other relevant trials, surveyed general practitioners and talked with physicians during pilot testing of the intervention. The post hoc exercise was carried out as focus groups of international researchers in the field of quality improvement in health care. The post hoc survey was done by telephone interviews with physicians allocated to the experimental group of a randomised trial of our multifaceted intervention. RESULTS: A wide range of barriers was identified and several interventions were suggested through structured reflection. The survey led to some adjustments. Studying other trials and pilot testing did not lead to changes in the design of the intervention. Neither the post hoc focus groups nor the post hoc survey revealed important barriers or interventions that we had not considered or included in our tailored intervention. CONCLUSIONS: A simple approach to identifying barriers to change appears to have been adequate and efficient. However, we do not know for certain what we would have gained by using more comprehensive methods and we do not know whether the resulting intervention would have been more effective if we had used other methods. The effectiveness of our multifaceted intervention is under evaluation in a randomised controlled trial

Health care through the `lens of risk' and the categorisation of health risks – An editorial

This editorial will introduce a four issue series of Risk, Health & Society special editions, Health Care Through the `Lens of Risk'. The editorial will argue that risk-thinking offers a particular approach to contingency, its culturally universal precursor. Contingency arises from the perception that one of two or more alternative outcomes might occur, or might have occurred. It addresses the infinity of possibility, and is properly located in minds rather than the material world in which singular events simply happen. The lens of risk renders contingency as the probability of a specified adverse event occurring within a particular time period. But each of the elements included in this definition can be reframed interpretively: events as categories; adversity as negative valuing; probabilities as uncertain expectations; and time periods as time frames. The editorial will outline this analysis, introduce the special issue series and briefly review the original research papers included in this first special issue which focuses on risk categorisation

Taking it to the bank: the ethical management of individual findings arising in secondary research

A rapidly growing proportion of health research uses ‘secondary data’: data used for purposes other than those for which it was originally collected. Do researchers using secondary data have an obligation to disclose individual research findings to participants? While the importance of this question has been duly recognised in the context of primary research (ie, where data are collected from participants directly), it remains largely unexamined in the context of research using secondary data. In this paper, we critically examine the arguments for a moral obligation to disclose individual research findings in the context of primary research, to determine if they can be applied to secondary research. We conclude that they cannot. We then propose that the nature of the relationship between researchers and participants is what gives rise to particular moral obligations, including the obligation to disclose individual results. We argue that the relationship between researchers and participants in secondary research does not generate an obligation to disclose. However, we also argue that the biobanks or data archives which collect and provide access to secondary data may have such an obligation, depending on the nature of the relationship they establish with participants