Multi-centre research in Australia:analysis of a recent National Health and Medical Research Council-funded project

BACKGROUND AND OBJECTIVE: Human research ethics committees provide essential review of research projects to ensure the ethical conduct of human research. Several recent reports have highlighted a complex process for successful application for human research ethics committee approval, particularly for multi-centre studies. Limited resources are available for the execution of human clinical research in Australia and around the world.

METHODS: This report overviews the process of ethics approval for a National Health and Medical Research Council-funded multi-centre study in Australia, focussing on the time and resource implications of such applications in 2007 and 2008.

RESULTS: Applications were submitted to 16 hospital and two university human research ethics committees. The total time to gain final approval from each committee ranged between 13 and 77 days (median = 46 days); the entire process took 16 months to complete and the research officer's time was estimated to cost $A34 143.

CONCLUSIONS: Obstacles to timely human research ethics committee approval are reviewed, including recent, planned and potential initiatives that could improve the ethics approval of multi-centre research.

Development of a Complex Intervention for Secondary Prevention of Coronary Heart Disease in Primary Care Using the UK Medical Research Council Framework

Objective: To apply the UK Medical Research Council (MRC) framework for development and evaluation of trials of complex interventions to a primary healthcare intervention to promote secondary prevention of coronary heart disease. Study Design: Case report of intervention development. Methods: First, literature relating to secondary prevention and lifestyle change was reviewed. Second, a preliminary intervention was modeled, based on literature findings and focus group interviews with patients (n = 23) and staff (n = 29) from 4 general practices. Participants’ experiences of and attitudes toward key intervention components were explored. Third, the preliminary intervention was pilot-tested in 4 general practices. After delivery of the pilot intervention, practitioners evaluated the training sessions, and qualitative data relating to experiences of the intervention were collected using semistructured interviews with staff (n = 10) and patient focus groups (n = 17). Results: Literature review identified 3 intervention components: a structured recall system, practitioner training, and patient information. Initial qualitative data identified variations in recall system design, training requirements (medication prescribing, facilitating behavior change), and information appropriate to the prospective study participants. Identifying detailed structures within intervention components clarified how the intervention could be tailored to individual practice, practitioner, and patient needs while preserving the theoretical functions of the components. Findings from the pilot phase informed further modeling of the intervention, reducing administrative time, increasing practical content of training, and omitting unhelpful patient information. Conclusion: Application of the MRC framework helped to determine the feasibility and development of a complex intervention for primary care research.

European Law and New Health Technologies ESRC End of Award Report, RES-451-26-0764

End of award report for the funded research seminar series of the same name.

European Law and New Health Technologies

Health is a matter of fundamental importance in European societies, both as a human right in itself, and as a factor in a productive workforce and therefore a healthy economy. New health technologies promise improved quality of life for patients suffering from a range of diseases, and the potential for the prevention of incidence of disease in the future. At the same time, new health technologies pose significant challenges for governments, particularly in relation to ensuring the technologies are safe, effective, and provide appropriate value for (public) money.

To guard against the possible dangers arising from new health technologies, and to maximize the benefits, all European governments regulate their development, marketing, and public financing. In addition, several international institutions operating at European level, in particular the European Union, the Council of Europe, and the European Patent Office, have become involved in the regulation of new health technologies. They have done so both through traditional 'command and control' legal measures, and through other regulatory mechanisms, including guidelines, soft law, 'steering' through redistribution of resources, and private or quasi-private regulation.

This collection analyses European law and its relationships with new health technologies. It uses interdisciplinary insights, particularly from law but also drawing on regulation theory, and science and technology studies, to shed new light on some of the key defining features of the relationships and especially the roles of risk, rights, ethics, and markets. The collection explores the way in which European law's engagement with new health technologies is to be legitimized, and discusses the implications for biological or biomedical citizenship.

Accessibility and Health: Towards Walkability Tools for Planning Practice

There is increasing research interest in how we can most effectively intervene in the built environment to change behaviours such as physical activity and improve health. Much of this work has focussed around the concept of walkability and the identification of those attributes of our cities that encourage pedestrian activity, including density, connectivity and the aesthetic of the urban realm (Saelens et al 2003, Frank et al 2010). Much of the existing research has clarified the strength of the relationships between various environmental attributes and the differential impact on different demographic groups (e.g. Panter et al 2011). This has not yet been effectively translated into tools to help integrate the concepts of walkability into decision-making by statutory authorities that can help shape the spatial development and delivery of public services which can support more active lifestyles. A key reason for this has been that standard models for transport planning and accessibility are based on networks of road infrastructure, which provides a weak basis for modelling pedestrian accessibility (Chin et al 2008).

This paper reports the findings of Knowledge Exchange project funded by UK’s Economic and Social Research Council (ES/J010588/1) and partners including Belfast and Derry City Councils and Northern Ireland’s Public Health Agency, the Department of Regional Development and Belfast Healthy Cities, that has attempted to address this problem. This project has mapped city-wide footpath networks and used these to assist partner organisations in developing the evidence base for making decisions on public services based on health impacts and pedestrian access. The paper describes the tool developed, uses a number of examples to highlight its impact on areas of decision-making and evaluates the benefits of further integrating walkability into planning and development practice.

Donegall Pass: Towards a sustainable community:Chapter 5, Health and Wellbeing

Key Points

International research has long since established a gradient between health and socio-economic status and it is now clear that the social and physical context in which people live can have a negative influence on health.

Recent research has established an adverse effect on the health of people who remained in an area that had become more deprived over time

The mechanisms thought to influence health in declining communities include stress, loss of self-esteem, stigma, powerlessness, a lack of hope and fatalism.

These mechanisms are related to the concept of social capital, a resource produced when people co-operate for mutual benefit

Residents’ key concerns relating to the decline in the community are housing shortages which are perceived to be contributing to the breakdown of the family-based community, along with traffic; pollution; non-resident parking problems; a lack of youth facilities; and the influx of ethnic minorities who are less inclined to become involved with the community

In the Donegall Pass a dual process of outward migration and business development has resulted in a decline in social capital within the community which was particularly evident amongst the younger generations

People living in deprived areas, such as the Donegall Pass, that are adjacent to affluent areas, such as the new apartment developments surrounding the area, can often feel relatively more deprived due to such direct comparisons. Although relative deprivation was evident, peer comparisons with the Donegal Road/Sandy Row community were more commonly expressed

The area can be described as a ‘food desert’ as no affordable fresh grocery supplies are available within walking distance

Residents expressed mixed opinions about the future of the Donegall Pass including a common sense of resignation towards the decline in the core community

Many residents recognise the need for people to work together and gain empowerment in order to work with the authorities (i.e., the Housing Executive and the Council) towards progressive re-development that is in keeping with the aims of the community members, however, equally many were impervious towards these suggestions feeling that previous efforts had gone unrewarded.

Personal and Public Involvement and its impact - Monitoring, measuring and evaluating the impact of Personal and Public Involvement (PPI) in Health and Social Care in Northern Ireland.

Introduction
This report details the findings from research conducted across Northern Ireland’s Health and Social Care Trusts during 2015 which examines the current state of Personal and Public Involvement (PPI). This is about how service users, carers and patients engage with staff, management and directors of statutory health and social care organisations. Most statutory health and social care organisations must, under legislation, meet the requirements of PPI. PPI has been part of health and social care policy in Northern Ireland since 2007 and became law two years later with the introduction of the Health and Social Care Reform Act (2009). It is, therefore, timely that PPI is now assessed in this systematic way in order to both examine the aspects which are working well and to highlight those areas where improvements need to be made. As far as possible, this Summary Report is written in an accessible way, avoiding jargon and explaining key research terms, so as to ensure it is widely understood. This is in keeping with established good practice in service user involvement research. This summary, therefore, gives a picture of PPI in Northern Ireland currently. There is also a fuller report which gives a lot more details about the research and findings. Information on this is available from the Public Health Agency and/or the Patient and Client Council.